<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03273738</url>
  </required_header>
  <id_info>
    <org_study_id>Postmenopausal DM</org_study_id>
    <nct_id>NCT03273738</nct_id>
  </id_info>
  <brief_title>Vascular and Metabolic Changes in Postmenopausal Diabetics</brief_title>
  <official_title>Assessment of Vascular and Metabolic Changes in Post-menopausal Women With Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The presence of type 2 diabetes mellitus (T2DM) also increases the relative risk of&#xD;
      developing cardiovascular disease in women compared to men. Carotid intima media thickness&#xD;
      (IMTc) was increased with reduction in brachial artery flow-mediated dilation (FMD) in T2 DM&#xD;
      patients and inversely and strongly related to the extent of hyperglycemia. Low&#xD;
      concentrations of folate and vitamin B12 involved in homocysteine metabolism are also&#xD;
      associated with increased risk of vascular damage. the aim is to relate, if found, the degree&#xD;
      of metabolic changes to the extent in vascular parameters changes in type 2 diabetic&#xD;
      postmenopausal women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction Complications of diabetes, such as cardiovascular disease, are associated with&#xD;
      increased mortality among type 2 diabetes mellitus patients. The presence of type 2 diabetes&#xD;
      mellitus (T2DM) also increases the relative risk of developing cardiovascular disease in&#xD;
      women compared to men . Major cardiovascular disease risk factors that have been identified&#xD;
      in T2DM patients include arterial stiffening, endothelial dysfunction, hyperglycemia , and&#xD;
      elevated glycated haemoglobin (HbA1c) concentrations.&#xD;
&#xD;
      Cardiovascular disease is the major cause of morbidity and mortality in T2 DM, due to&#xD;
      arterial structure and functional changes. Evaluation of vascular dysfunction in T2 DM&#xD;
      patients include: carotid intima media thickness (IMTc), pulse wave velocity (PWV), and&#xD;
      brachial artery flow-mediated dilation (FMD). IMTc is increased in patients with T2 DM with&#xD;
      reductions in FMD, which have already been reported to be inversely and strongly related to&#xD;
      the extent of hyperglycemia.&#xD;
&#xD;
      The incidence of vascular complications is multifactorial and may not be explained by&#xD;
      hyperglycemia alone. Other presumably unrelated risk factors, such as hyperhomocysteinemia&#xD;
      may be involved in the atherothrombotic process. High levels of homocysteine have been&#xD;
      identified as a risk factor for cardiovascular disease in T2DM patients. Levels of plasma&#xD;
      homocysteine increase in women after menopause, and postmenopausal diabetic women are&#xD;
      consequently at significantly increased risk of cardiovascular disease.&#xD;
&#xD;
      High concentrations of homocysteine are associated with increased low-density lipoprotein&#xD;
      oxidation, endothelial dysfunction, dysfunction of β-islet cells and inhibiting secretion of&#xD;
      insulin. Also, hyperhomocysteinemia was an independent risk factor for the occurrence of&#xD;
      diabetic peripheral neuropathy .&#xD;
&#xD;
      In newly diagnosed normotensive T2DM patients, the left ventricular mass index (LVMI),&#xD;
      carotid intima media thickness (CIMT), and creatinine levels and 24-hr microalbuminuria were&#xD;
      used to determine cardiac, carotid, and kidney end-organ diseases, respectively. It was found&#xD;
      that, LVMI, CIMT, and creatinine level were positively correlated with the homocysteine&#xD;
      level.&#xD;
&#xD;
      Moreover, determinants of hyperhomocysteinemia, such as low concentrations of folate and&#xD;
      vitamin B12 involved in homocysteine metabolism are also associated with increased risk of&#xD;
      vascular damage. Folic acid supplementation may improve the cardiovascular health of&#xD;
      post-menopausal women with diabetes, reduce homocysteine levels and improve vascular health&#xD;
      in different study populations.&#xD;
&#xD;
      Increased plasma homocysteine, triglyceride and waist circumference as well as decreased&#xD;
      folic acid and vitamin B12 in type 2 diabetes mellitus were evaluated.&#xD;
&#xD;
      Sudchada et al. concluded that folic acid supplementation in patient with T2DM may reduce&#xD;
      total homocysteine levels and have a trend to associate with better glycemic control compared&#xD;
      with placebo.&#xD;
&#xD;
      in postmenopausal Korean women with type 2 diabetes mellitus, folic acid supplementation&#xD;
      reduced serum homocysteine levels, increased serum folate and vitamin B12 levels, and lowered&#xD;
      lipid parameters.&#xD;
&#xD;
      A case-control study showed that low intakes of folate and B12 in type 2 diabetic patients&#xD;
      were associated with hyperhomocysteinemia. Additionally, folate has also been shown to&#xD;
      improve glycemic control by reducing glycosylated hemoglobin fasting blood glucose, serum&#xD;
      insulin and insulin resistance as well as homocysteinemia in type 2 diabetes patients.&#xD;
&#xD;
      Folic acid supplementation significantly reduced LDL-C levels as well as LDL-C/HDL-C and&#xD;
      TC/HDL-C ratios. The improvements in lipid parameters might be due to the reduction of serum&#xD;
      homocysteine levels caused by folic acid supplementation. In another study, associations&#xD;
      between fasting plasma homocysteine concentration and age, serum creatinine, and vitamin B12.&#xD;
      However, no association between folate and homocysteine was found.&#xD;
&#xD;
      Whether serum homocysteine levels are associated with coronary heart disease (CHD) and the&#xD;
      metabolic syndrome (MS) needs investigation in different ethnic groups. High serum&#xD;
      homocysteine and low folate levels are associated in Turkish men independently with coronary&#xD;
      heart disease, which needs confirmation in a larger sample. In women, vitamin B12&#xD;
      concentrations are significantly associated with metabolic syndrome likelihood.&#xD;
&#xD;
      there is no support that metformin consumption increases homocysteine secondary to folate and&#xD;
      /or B12 deficiency in patients with T2DM. Also, among adults with hypertension with no&#xD;
      history of stroke and/or myocardial infarction, folic acid supplementation had no significant&#xD;
      effect on the risk of new-onset diabetes.&#xD;
&#xD;
      However, clinical studies have shown that folic acid therapy is not very effective in&#xD;
      normalizing hyperhomocysteinemia in uremic patients. Indeed, it has been demonstrated that&#xD;
      vitamin B12 supplementation alone, or in combination with folic acid, decreases total&#xD;
      homocysteine concentrations, but full normalization is not achieved. folate levels were&#xD;
      comparable to controls at various chronic kidney disease stages, whereas vitamin B12 levels&#xD;
      were lower, except at stage IV in patients with T2DM. They did not find any correlation&#xD;
      between B-vitamins and levels of total homocysteine and cysteine, regardless of the CKD&#xD;
      stage.&#xD;
&#xD;
      Aims of the study:&#xD;
&#xD;
        1. To evaluate cardiovascular changes in type 2 diabetic postmenopausal women through&#xD;
           measurement of vascular parameters.&#xD;
&#xD;
        2. To assess the possible changes in some metabolic features in type 2 diabetic&#xD;
           postmenopausal women.&#xD;
&#xD;
        3. To relate, if found, the degree of metabolic changes to the extent in vascular&#xD;
           parameters changes in type 2 diabetic postmenopausal women.&#xD;
&#xD;
      Type of study and its design:&#xD;
&#xD;
      Study subjects:&#xD;
&#xD;
      This study will include 50 female patients with T2DM who visited Assiut University Hospital&#xD;
      Diabetes Clinic in Assiut, Egypt. Another 50 participants will be volunteered in the study as&#xD;
      control.&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
      For this study, 100 post-menopausal women aged 50-70 years with amenorrhea for over 24 months&#xD;
      will be recruited. The diabetic participants will receive their treatment for T2DM (oral&#xD;
      hypoglycemic agents or insulin).&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
        1. Patients receiving hormone replacement therapy.&#xD;
&#xD;
        2. History of abnormal vaginal bleeding.&#xD;
&#xD;
        3. Patients receiving vitamin B12, vitamin D and folic acid regularly.&#xD;
&#xD;
        4. History of malignancy or neurological diseases as epilepsy, parkinsonism and Alzheimer&#xD;
           disease.&#xD;
&#xD;
        5. Antifolate medications as methotrexate are excluded from the study.&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      The study will be observational study. The participants will be informed about the study and&#xD;
      we will take their assignment on written consent. The patients included will be divided into&#xD;
      two groups. 20 healthy participants and 100 female patients, will be subjected to clinical&#xD;
      evaluation and blood sampling for laboratory investigations.&#xD;
&#xD;
      Evaluation of the patients:&#xD;
&#xD;
      All patients will be subjected to:&#xD;
&#xD;
        1. Complete history (age, occupation, menstrual history, bleeding tendency, renal disease,&#xD;
           therapeutic and dietary history)&#xD;
&#xD;
        2. Clinical examination (weight, height, blood pressure measurement, presence of&#xD;
           microvascular or macrovascular complications, anemia).&#xD;
&#xD;
        3. ECG.&#xD;
&#xD;
        4. Brachial-ankle pulse wave velocity (baPWV) will be calculated further using the&#xD;
           following equation:&#xD;
&#xD;
           baPWV = transmission distance/transmission time&#xD;
&#xD;
        5. Carotid intima-media thickness (CIMT) will be done, it is noninvasive measure that uses&#xD;
           ultrasound to detect the presence and extent of atherosclerosis.&#xD;
&#xD;
        6. Laboratory investigations:&#xD;
&#xD;
             1. HbA1c.&#xD;
&#xD;
             2. Lipid profiles (total cholesterol, LDL-C, HDL-C and triglycerides)&#xD;
&#xD;
             3. Serum homocysteine will be measured using available commercial ELISA kits.&#xD;
&#xD;
             4. Serum folic acid level will be measured using available commercial ELISA kits.&#xD;
&#xD;
             1. Serum vitamin B12 level will be measured using available commercial ELISA kits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 2, 2018</start_date>
  <completion_date type="Anticipated">November 15, 2018</completion_date>
  <primary_completion_date type="Anticipated">October 10, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>metabolic changes in type 2 diabetes</measure>
    <time_frame>baseline and 3 months</time_frame>
    <description>changes in folate level in type 2 diabetes mellitus</description>
  </primary_outcome>
  <primary_outcome>
    <measure>metabolic changes in type 2 diabetes</measure>
    <time_frame>baseline and 3 months</time_frame>
    <description>B12 level and their relation to complications</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Diabete Type 2</condition>
  <arm_group>
    <arm_group_label>postmenopausal diabetic women</arm_group_label>
    <description>50 female patients with T2DM who visited Assiut University Hospital Diabetes Clinic in Assiut, Egypt in these patients folate level measurement, B12 level and homocysteine are measured</description>
  </arm_group>
  <arm_group>
    <arm_group_label>postmenopausal without diabetes</arm_group_label>
    <description>Another 50 participants will be volunteered in the study as control.n these subjects folate level measurement', B12 level and homocysteine are measured</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>folate level measurement</intervention_name>
    <description>the level of folate measured in plasma with homocysteine</description>
    <arm_group_label>postmenopausal diabetic women</arm_group_label>
    <arm_group_label>postmenopausal without diabetes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>B12</intervention_name>
    <description>B12 measurement in blood</description>
    <arm_group_label>postmenopausal diabetic women</arm_group_label>
    <arm_group_label>postmenopausal without diabetes</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        post-menopausal women aged 50-70 years with amenorrhea for over 24 months will be&#xD;
        recruited. The diabetic participants will receive their treatment for T2DM (oral&#xD;
        hypoglycemic agents or insulin).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  post-menopausal women&#xD;
&#xD;
          -  aged 50-70 years&#xD;
&#xD;
          -  amenorrhea for over 24 months.&#xD;
&#xD;
          -  The diabetic participants will receive their treatment for T2DM (oral hypoglycemic&#xD;
             agents or insulin).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients receiving hormone replacement therapy.&#xD;
&#xD;
          -  History of abnormal vaginal bleeding.&#xD;
&#xD;
          -  Patients receiving vitamin B12, vitamin D and folic acid regularly.&#xD;
&#xD;
          -  History of malignancy or neurological diseases as epilepsy, parkinsonism and Alzheimer&#xD;
             disease.&#xD;
&#xD;
          -  Antifolate medications as methotrexate are excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>postmenopausal women</gender_description>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lobna F Eltoony</last_name>
    <role>Study Chair</role>
    <affiliation>internal medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed M Abd-Eldayem, MD</last_name>
    <phone>01005885676</phone>
    <phone_ext>002</phone_ext>
    <email>ah_nmre@yahoo.com</email>
  </overall_contact>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>June 26, 2018</last_update_submitted>
  <last_update_submitted_qc>June 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ahmed Mohammed</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>type 2 diabetes</keyword>
  <keyword>postmenopausal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>share measurements results in medical journals</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03273738
org study id: Postmenopausal DM
nct id: NCT03273738
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The presence of type 2 diabetes mellitus (T2DM) also increases the relative risk of
      developing cardiovascular disease in women compared to men. Carotid intima media thickness
      (IMTc) was increased with reduction in brachial artery flow-mediated dilation (FMD) in T2 DM
      patients and inversely and strongly related to the extent of hyperglycemia. Low
      concentrations of folate and vitamin B12 involved in homocysteine metabolism are also
      associated with increased risk of vascular damage. the aim is to relate, if found, the degree
      of metabolic changes to the extent in vascular parameters changes in type 2 diabetic
      postmenopausal women.
Introduction Complications of diabetes, such as cardiovascular disease, are associated with
      increased mortality among type 2 diabetes mellitus patients. The presence of type 2 diabetes
      mellitus (T2DM) also increases the relative risk of developing cardiovascular disease in
      women compared to men . Major cardiovascular disease risk factors that have been identified
      in T2DM patients include arterial stiffening, endothelial dysfunction, hyperglycemia , and
      elevated glycated haemoglobin (HbA1c) concentrations.

      Cardiovascular disease is the major cause of morbidity and mortality in T2 DM, due to
      arterial structure and functional changes. Evaluation of vascular dysfunction in T2 DM
      patients include: carotid intima media thickness (IMTc), pulse wave velocity (PWV), and
      brachial artery flow-mediated dilation (FMD). IMTc is increased in patients with T2 DM with
      reductions in FMD, which have already been reported to be inversely and strongly related to
      the extent of hyperglycemia.

      The incidence of vascular complications is multifactorial and may not be explained by
      hyperglycemia alone. Other presumably unrelated risk factors, such as hyperhomocysteinemia
      may be involved in the atherothrombotic process. High levels of homocysteine have been
      identified as a risk factor for cardiovascular disease in T2DM patients. Levels of plasma
      homocysteine increase in women after menopause, and postmenopausal diabetic women are
      consequently at significantly increased risk of cardiovascular disease.

      High concentrations of homocysteine are associated with increased low-density lipoprotein
      oxidation, endothelial dysfunction, dysfunction of β-islet cells and inhibiting secretion of
      insulin. Also, hyperhomocysteinemia was an independent risk factor for the occurrence of
      diabetic peripheral neuropathy .

      In newly diagnosed normotensive T2DM patients, the left ventricular mass index (LVMI),
      carotid intima media thickness (CIMT), and creatinine levels and 24-hr microalbuminuria were
      used to determine cardiac, carotid, and kidney end-organ diseases, respectively. It was found
      that, LVMI, CIMT, and creatinine level were positively correlated with the homocysteine
      level.

      Moreover, determinants of hyperhomocysteinemia, such as low concentrations of folate and
      vitamin B12 involved in homocysteine metabolism are also associated with increased risk of
      vascular damage. Folic acid supplementation may improve the cardiovascular health of
      post-menopausal women with diabetes, reduce homocysteine levels and improve vascular health
      in different study populations.

      Increased plasma homocysteine, triglyceride and waist circumference as well as decreased
      folic acid and vitamin B12 in type 2 diabetes mellitus were evaluated.

      Sudchada et al. concluded that folic acid supplementation in patient with T2DM may reduce
      total homocysteine levels and have a trend to associate with better glycemic control compared
      with placebo.

      in postmenopausal Korean women with type 2 diabetes mellitus, folic acid supplementation
      reduced serum homocysteine levels, increased serum folate and vitamin B12 levels, and lowered
      lipid parameters.

      A case-control study showed that low intakes of folate and B12 in type 2 diabetic patients
      were associated with hyperhomocysteinemia. Additionally, folate has also been shown to
      improve glycemic control by reducing glycosylated hemoglobin fasting blood glucose, serum
      insulin and insulin resistance as well as homocysteinemia in type 2 diabetes patients.

      Folic acid supplementation significantly reduced LDL-C levels as well as LDL-C/HDL-C and
      TC/HDL-C ratios. The improvements in lipid parameters might be due to the reduction of serum
      homocysteine levels caused by folic acid supplementation. In another study, associations
      between fasting plasma homocysteine concentration and age, serum creatinine, and vitamin B12.
      However, no association between folate and homocysteine was found.

      Whether serum homocysteine levels are associated with coronary heart disease (CHD) and the
      metabolic syndrome (MS) needs investigation in different ethnic groups. High serum
      homocysteine and low folate levels are associated in Turkish men independently with coronary
      heart disease, which needs confirmation in a larger sample. In women, vitamin B12
      concentrations are significantly associated with metabolic syndrome likelihood.

      there is no support that metformin consumption increases homocysteine secondary to folate and
      /or B12 deficiency in patients with T2DM. Also, among adults with hypertension with no
      history of stroke and/or myocardial infarction, folic acid supplementation had no significant
      effect on the risk of new-onset diabetes.

      However, clinical studies have shown that folic acid therapy is not very effective in
      normalizing hyperhomocysteinemia in uremic patients. Indeed, it has been demonstrated that
      vitamin B12 supplementation alone, or in combination with folic acid, decreases total
      homocysteine concentrations, but full normalization is not achieved. folate levels were
      comparable to controls at various chronic kidney disease stages, whereas vitamin B12 levels
      were lower, except at stage IV in patients with T2DM. They did not find any correlation
      between B-vitamins and levels of total homocysteine and cysteine, regardless of the CKD
      stage.

      Aims of the study:

        1. To evaluate cardiovascular changes in type 2 diabetic postmenopausal women through
           measurement of vascular parameters.

        2. To assess the possible changes in some metabolic features in type 2 diabetic
           postmenopausal women.

        3. To relate, if found, the degree of metabolic changes to the extent in vascular
           parameters changes in type 2 diabetic postmenopausal women.

      Type of study and its design:

      Study subjects:

      This study will include 50 female patients with T2DM who visited Assiut University Hospital
      Diabetes Clinic in Assiut, Egypt. Another 50 participants will be volunteered in the study as
      control.

      Inclusion criteria:

      For this study, 100 post-menopausal women aged 50-70 years with amenorrhea for over 24 months
      will be recruited. The diabetic participants will receive their treatment for T2DM (oral
      hypoglycemic agents or insulin).

      Exclusion criteria:

        1. Patients receiving hormone replacement therapy.

        2. History of abnormal vaginal bleeding.

        3. Patients receiving vitamin B12, vitamin D and folic acid regularly.

        4. History of malignancy or neurological diseases as epilepsy, parkinsonism and Alzheimer
           disease.

        5. Antifolate medications as methotrexate are excluded from the study.

      Study design:

      The study will be observational study. The participants will be informed about the study and
      we will take their assignment on written consent. The patients included will be divided into
      two groups. 20 healthy participants and 100 female patients, will be subjected to clinical
      evaluation and blood sampling for laboratory investigations.

      Evaluation of the patients:

      All patients will be subjected to:

        1. Complete history (age, occupation, menstrual history, bleeding tendency, renal disease,
           therapeutic and dietary history)

        2. Clinical examination (weight, height, blood pressure measurement, presence of
           microvascular or macrovascular complications, anemia).

        3. ECG.

        4. Brachial-ankle pulse wave velocity (baPWV) will be calculated further using the
           following equation:

           baPWV = transmission distance/transmission time

        5. Carotid intima-media thickness (CIMT) will be done, it is noninvasive measure that uses
           ultrasound to detect the presence and extent of atherosclerosis.

        6. Laboratory investigations:

             1. HbA1c.

             2. Lipid profiles (total cholesterol, LDL-C, HDL-C and triglycerides)

             3. Serum homocysteine will be measured using available commercial ELISA kits.

             4. Serum folic acid level will be measured using available commercial ELISA kits.

             1. Serum vitamin B12 level will be measured using available commercial ELISA kits.
observational model: Case-Control
time perspective: Retrospective
measure: metabolic changes in type 2 diabetes
time frame: baseline and 3 months
description: changes in folate level in type 2 diabetes mellitus
measure: metabolic changes in type 2 diabetes
time frame: baseline and 3 months
description: B12 level and their relation to complications
arm group label: postmenopausal diabetic women
description: 50 female patients with T2DM who visited Assiut University Hospital Diabetes Clinic in Assiut, Egypt in these patients folate level measurement, B12 level and homocysteine are measured
arm group label: postmenopausal without diabetes
description: Another 50 participants will be volunteered in the study as control.n these subjects folate level measurement', B12 level and homocysteine are measured
intervention type: Diagnostic Test
intervention name: folate level measurement
description: the level of folate measured in plasma with homocysteine
arm group label: postmenopausal diabetic women
arm group label: postmenopausal without diabetes
intervention type: Diagnostic Test
intervention name: B12
description: B12 measurement in blood
arm group label: postmenopausal diabetic women
arm group label: postmenopausal without diabetes
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: postmenopausal women
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lobna F Eltoony
role: Study Chair
affiliation: internal medicine
last name: Ahmed M Abd-Eldayem, MD
phone: 01005885676
phone ext: 002
email: ah_nmre@yahoo.com
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ahmed Mohammed
investigator title: principal investigator
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Undecided
ipd description: share measurements results in medical journals