<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/NCT03829800</url>
  </required_header>
  <id_info>
    <org_study_id>1001092016</org_study_id>
    <nct_id>NCT03829800</nct_id>
  </id_info>
  <brief_title>Formulas for Diabetes With Sucromalt &amp; Isomaltulose on Glycemic Index, Hormones &amp; Subjective Appetite in Type 2 Diabetes</brief_title>
  <official_title>Effect of the Intake of Specific Formulas for Diabetes With Sucromalt and Isomaltulose on the Glycemic Index, Insulin, Glucagon-like Peptide-1, Gastric Inhibitory Peptide Levels and Subjective Appetite in Subjects With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad del Zulia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad del Zulia</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Consumption of nutritional supplements with low glycemic carbohydrates induce favorable&#xD;
      glycemic responses in subjects with type 2 diabetes. The aim of this study was to compare the&#xD;
      effect of the intake of specific formulas for diabetes, with different types of carbohydrates&#xD;
      (isomaltulose and sucromaltose) on the glycemic response, release of intestinal peptides and&#xD;
      subjective appetite in Type 2 diabetic individuals. In a randomized, double-blind, cross-over&#xD;
      study of 4 treatments, 16 subjects (56.60 ± 1.11 years). Fasting blood samples were taking,&#xD;
      after that they were given to consume formula or reference product assigned randomly.&#xD;
      Subsequently, samples of capillary and venous blood were obtained at times 30, 60, 90, 120&#xD;
      and 180 min, after the start of consumption of the experimental beverage for the measurement&#xD;
      of glucose, insulin, gastric inhibitory peptide (GIP) and glucagon-like peptide-1 (GLP-1).&#xD;
      The assessment of subjective appetite was measured by Visual Analogue Scale (VAS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a randomized, double-blind, cross-over study of 4 treatments that was conducted&#xD;
      according to the Good Clinical Practice Guidelines, with all applicable Food and Drug privacy&#xD;
      regulations, and ethical principles based on the Declaration of Helsinki. Participants signed&#xD;
      informed consent, approved by the Human Research Ethics Committee of the Endocrine-Metabolic&#xD;
      Research Center of the University of Zulia, in Venezuela. All selected subjects attended a&#xD;
      first visit, in order to determine if they met the inclusion criteria, those who gathered&#xD;
      them, were subjected to four consumption tests to determine the glycemic index (GI) and&#xD;
      glycemic load (GL) and 3 consumption tests for the evaluation of subjective appetite. Each&#xD;
      treatment or consumption session was carried out on different days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2016</start_date>
  <completion_date type="Actual">November 15, 2018</completion_date>
  <primary_completion_date type="Actual">September 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Participants receive 4 nutritional formulas to evaluate their glycemic index, insulin, GLP-1, GIP levels and subjective appetite</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline Glycemia at 180 minutes</measure>
    <time_frame>Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.</time_frame>
    <description>mmol/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline Insulin at 180 minutes</measure>
    <time_frame>Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.</time_frame>
    <description>milliunits per liter (mU/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glycemic Index (GI)</measure>
    <time_frame>180 minutes after intake of each formula</time_frame>
    <description>Low GI (≤ 55), Intermediate (55-69) and High (≥70)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glycemic Load (GL)</measure>
    <time_frame>180 minutes after intake of each formula</time_frame>
    <description>High GL (&gt; 20), Intermediate GL (11-19) and Low GL (&lt;10)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline GLP-1 at 180 minutes</measure>
    <time_frame>Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.</time_frame>
    <description>pmol/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline GIP at 180 minutes</measure>
    <time_frame>Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.</time_frame>
    <description>pg/mL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline Hunger at 180 minutes</measure>
    <time_frame>Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.</time_frame>
    <description>Visual Analogue Scale (mm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline Fullness at 180 minutes</measure>
    <time_frame>Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.</time_frame>
    <description>Visual Analogue Scale (mm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline Desire to eat at 180 minutes</measure>
    <time_frame>Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.</time_frame>
    <description>Visual Analogue Scale (mm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline Prospective food consumption at 180 minutes</measure>
    <time_frame>Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.</time_frame>
    <description>Visual Analogue Scale (mm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline Subjective appetite at 180 minutes</measure>
    <time_frame>Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.</time_frame>
    <description>Visual Analogue Scale (mm)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Age</measure>
    <time_frame>Baseline</time_frame>
    <description>years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>Baseline</time_frame>
    <description>kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>Baseline</time_frame>
    <description>m</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>Baseline</time_frame>
    <description>kg/m^2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip Circumference</measure>
    <time_frame>Baseline</time_frame>
    <description>cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Cholesterol</measure>
    <time_frame>Baseline</time_frame>
    <description>mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL-C</measure>
    <time_frame>Baseline</time_frame>
    <description>mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL-C</measure>
    <time_frame>Baseline</time_frame>
    <description>mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triacylglycerides</measure>
    <time_frame>Baseline</time_frame>
    <description>mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>Baseline</time_frame>
    <description>percentage (%)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Ensure® Abbott Nutrition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A standard nutritional formula not specific for diabetics</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glucerna® Abbott Nutrition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A formula with a patented blend of slow-digesting carbohydrates including resistant maltodextrin and sucromalt</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diasip® Nutricia Advanced</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A formula whose composition has isomaltulose and resistant starch</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glicolab®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Glucose solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Ensure® Abbott Nutrition</intervention_name>
    <description>Effect of the intake of Ensure® Abbott Nutrition on the glycemic index, insulin, GLP-1, GIP levels and subjective appetite in subjects with type 2 diabetes</description>
    <arm_group_label>Ensure® Abbott Nutrition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Glucerna® Abbott Nutrition</intervention_name>
    <description>Effect of the intake of Glucerna® Abbott Nutrition on the glycemic index, insulin, GLP-1, GIP levels and subjective appetite in subjects with type 2 diabetes</description>
    <arm_group_label>Glucerna® Abbott Nutrition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Diasip® Nutricia Advanced</intervention_name>
    <description>Effect of the intake of Diasip® Nutricia Advanced on the glycemic index, insulin, GLP-1, GIP levels and subjective appetite in subjects with type 2 diabetes</description>
    <arm_group_label>Diasip® Nutricia Advanced</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Glicolab®</intervention_name>
    <description>Effect of the intake of Glicolab on the glycemic index, insulin and subjective appetite in subjects with type 2 diabetes</description>
    <arm_group_label>Glicolab®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 Diabetes&#xD;
&#xD;
          -  Demonstrated use of oral hypoglycemic agents (metformin), for at least two months&#xD;
&#xD;
          -  BMI of 18.5 kg/m2 to ≤ 35 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Type 1 Diabetes&#xD;
&#xD;
          -  Diabetic ketoacidosis&#xD;
&#xD;
          -  Congestive heart failure&#xD;
&#xD;
          -  Gastric, renal or hepatic diseases&#xD;
&#xD;
          -  Myocardial infarction&#xD;
&#xD;
          -  Stroke&#xD;
&#xD;
          -  Subjects with insulin therapy, antibiotic therapy or corticosteroids&#xD;
&#xD;
          -  End-stage organ failure&#xD;
&#xD;
          -  Individuals with organ transplantation&#xD;
&#xD;
          -  Coagulation or bleeding disorder&#xD;
&#xD;
          -  Infectious or chronic contagious disease (such as tuberculosis, hepatitis B or C or&#xD;
             HIV).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>51 Years</minimum_age>
    <maximum_age>63 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisse Angarita, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad Andrés Bello, Facultad de Medicina - Sede Concepción</affiliation>
  </overall_official>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>February 1, 2019</last_update_submitted>
  <last_update_submitted_qc>February 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad del Zulia</investigator_affiliation>
    <investigator_full_name>Daniel J Aparicio Camargo</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Glycemic Index</keyword>
  <keyword>Insulin</keyword>
  <keyword>Incretins</keyword>
  <keyword>Diabetes Mellitus type 2</keyword>
  <keyword>Subjective appetite</keyword>
  <keyword>Nutritional formula</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03829800
org study id: 1001092016
nct id: NCT03829800
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Consumption of nutritional supplements with low glycemic carbohydrates induce favorable
      glycemic responses in subjects with type 2 diabetes. The aim of this study was to compare the
      effect of the intake of specific formulas for diabetes, with different types of carbohydrates
      (isomaltulose and sucromaltose) on the glycemic response, release of intestinal peptides and
      subjective appetite in Type 2 diabetic individuals. In a randomized, double-blind, cross-over
      study of 4 treatments, 16 subjects (56.60 ± 1.11 years). Fasting blood samples were taking,
      after that they were given to consume formula or reference product assigned randomly.
      Subsequently, samples of capillary and venous blood were obtained at times 30, 60, 90, 120
      and 180 min, after the start of consumption of the experimental beverage for the measurement
      of glucose, insulin, gastric inhibitory peptide (GIP) and glucagon-like peptide-1 (GLP-1).
      The assessment of subjective appetite was measured by Visual Analogue Scale (VAS).
This was a randomized, double-blind, cross-over study of 4 treatments that was conducted
      according to the Good Clinical Practice Guidelines, with all applicable Food and Drug privacy
      regulations, and ethical principles based on the Declaration of Helsinki. Participants signed
      informed consent, approved by the Human Research Ethics Committee of the Endocrine-Metabolic
      Research Center of the University of Zulia, in Venezuela. All selected subjects attended a
      first visit, in order to determine if they met the inclusion criteria, those who gathered
      them, were subjected to four consumption tests to determine the glycemic index (GI) and
      glycemic load (GL) and 3 consumption tests for the evaluation of subjective appetite. Each
      treatment or consumption session was carried out on different days.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Participants receive 4 nutritional formulas to evaluate their glycemic index, insulin, GLP-1, GIP levels and subjective appetite
primary purpose: Basic Science
masking: Double (Participant, Care Provider)
measure: Change from baseline Glycemia at 180 minutes
time frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
description: mmol/L
measure: Change from baseline Insulin at 180 minutes
time frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
description: milliunits per liter (mU/L)
measure: Glycemic Index (GI)
time frame: 180 minutes after intake of each formula
description: Low GI (≤ 55), Intermediate (55-69) and High (≥70)
measure: Glycemic Load (GL)
time frame: 180 minutes after intake of each formula
description: High GL (> 20), Intermediate GL (11-19) and Low GL (<10)
measure: Change from baseline GLP-1 at 180 minutes
time frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
description: pmol/L
measure: Change from baseline GIP at 180 minutes
time frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
description: pg/mL
measure: Change from baseline Hunger at 180 minutes
time frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
description: Visual Analogue Scale (mm)
measure: Change from baseline Fullness at 180 minutes
time frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
description: Visual Analogue Scale (mm)
measure: Change from baseline Desire to eat at 180 minutes
time frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
description: Visual Analogue Scale (mm)
measure: Change from baseline Prospective food consumption at 180 minutes
time frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
description: Visual Analogue Scale (mm)
measure: Change from baseline Subjective appetite at 180 minutes
time frame: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
description: Visual Analogue Scale (mm)
measure: Age
time frame: Baseline
description: years
measure: Weight
time frame: Baseline
description: kg
measure: Height
time frame: Baseline
description: m
measure: Body Mass Index
time frame: Baseline
description: kg/m^2
measure: Hip Circumference
time frame: Baseline
description: cm
measure: Total Cholesterol
time frame: Baseline
description: mg/dl
measure: HDL-C
time frame: Baseline
description: mg/dl
measure: LDL-C
time frame: Baseline
description: mg/dl
measure: Triacylglycerides
time frame: Baseline
description: mg/dl
measure: HbA1c
time frame: Baseline
description: percentage (%)
arm group label: Ensure® Abbott Nutrition
arm group type: Experimental
description: A standard nutritional formula not specific for diabetics
arm group label: Glucerna® Abbott Nutrition
arm group type: Experimental
description: A formula with a patented blend of slow-digesting carbohydrates including resistant maltodextrin and sucromalt
arm group label: Diasip® Nutricia Advanced
arm group type: Experimental
description: A formula whose composition has isomaltulose and resistant starch
arm group label: Glicolab®
arm group type: Active Comparator
description: Glucose solution
intervention type: Dietary Supplement
intervention name: Ensure® Abbott Nutrition
description: Effect of the intake of Ensure® Abbott Nutrition on the glycemic index, insulin, GLP-1, GIP levels and subjective appetite in subjects with type 2 diabetes
arm group label: Ensure® Abbott Nutrition
intervention type: Dietary Supplement
intervention name: Glucerna® Abbott Nutrition
description: Effect of the intake of Glucerna® Abbott Nutrition on the glycemic index, insulin, GLP-1, GIP levels and subjective appetite in subjects with type 2 diabetes
arm group label: Glucerna® Abbott Nutrition
intervention type: Dietary Supplement
intervention name: Diasip® Nutricia Advanced
description: Effect of the intake of Diasip® Nutricia Advanced on the glycemic index, insulin, GLP-1, GIP levels and subjective appetite in subjects with type 2 diabetes
arm group label: Diasip® Nutricia Advanced
intervention type: Dietary Supplement
intervention name: Glicolab®
description: Effect of the intake of Glicolab on the glycemic index, insulin and subjective appetite in subjects with type 2 diabetes
arm group label: Glicolab®
criteria: 
gender: All
minimum age: 51 Years
maximum age: 63 Years
healthy volunteers: No
last name: Lisse Angarita, PhD
role: Principal Investigator
affiliation: Universidad Andrés Bello, Facultad de Medicina - Sede Concepción
responsible party type: Principal Investigator
investigator affiliation: Universidad del Zulia
investigator full name: Daniel J Aparicio Camargo
investigator title: Principal Investigator
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No