<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/NCT03294915</url>
  </required_header>
  <id_info>
    <org_study_id>15-0155</org_study_id>
    <nct_id>NCT03294915</nct_id>
  </id_info>
  <brief_title>Effect of Resistant Starch on Insulin Sensitivity and Beta Cell Function in Subjects With Prediabetes</brief_title>
  <official_title>Effect of Resistant Starch From Green Banana Flour on the Insulin Sensitivity of Subjects With Prediabetes: Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</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>
      To compare the use supplementation based on green banana flour versus placebo in the insulin&#xD;
      sensitivity on individuals who have prediabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In order to evaluate whether supplementation with green banana flour may improve insulin&#xD;
      sensitivity of individuals with prediabetes, volunteers will be recruited by advertising on&#xD;
      the web page of Hospital de Clinical de Porto Alegre. After screening and selection, they&#xD;
      will be submitted to a clinical, laboratory and nutritional standard evaluation, assessment&#xD;
      of physical activity and body fat composition.The laboratory evaluation will include the oral&#xD;
      glucose tolerance test (OGGT 75g), lipid profile, insulin, C-peptide, glycated hemoglobin and&#xD;
      glycated albumin. Insulin sensitivity and beta-cell function will be assessed by the&#xD;
      hyperglycemic CLAMP before and after the intervention.Interim statistical analysis will be&#xD;
      performed at the end of the participation of ten study volunteers.&#xD;
&#xD;
      Subjects will receive green banana flour or placebo for four weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 2018</start_date>
  <completion_date type="Anticipated">May 2020</completion_date>
  <primary_completion_date type="Anticipated">August 2019</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insulin sensitivity</measure>
    <time_frame>4 weeks</time_frame>
    <description>Insulin sensitivity compared to the baseline visit measured by hyperglycemia clamp</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hormonal changes</measure>
    <time_frame>4 weeks</time_frame>
    <description>Alteration of hormones that affect glucose metabolism, such as peptide C</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lipid profile</measure>
    <time_frame>4 weeks</time_frame>
    <description>Alteration of total cholesterol, HDL-cholesterol and triglycerides</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change total body fat</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change total body fat will be compared before and after the intervention by means of bioimpedance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beta cell function</measure>
    <time_frame>4 weeks</time_frame>
    <description>Beta cell function (first and second phase of insulin secretion) will be measured by hyperglycemic clamp</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic control</measure>
    <time_frame>4 weeks</time_frame>
    <description>Measured by hemoglobin glycated</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Prediabetes</condition>
  <arm_group>
    <arm_group_label>Resistant Starch</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Green banana flour</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Maltodextrin, cellulose and guar gum</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Resistant Starch</intervention_name>
    <description>Addition of 42g per day of green banana flour (10g / day resistant starch) to the usual diet of study participants</description>
    <arm_group_label>Resistant Starch</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Addition of 42g per day of mixture of guar gum, maltodextrin and cellulose to the usual diet of study participants</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          1. Serum glycated hemoglobin (A1c) values between 5.7 and 6.5%, or fasting glucose ≥ 5.55&#xD;
             mmol/L and &lt; 6.94 mmol/L or oral glucose tolerance test (75g) ≥7.77 and &lt;11.04 mmol&#xD;
             /L.&#xD;
&#xD;
          2. Body mass index (BMI) ≥ 25 kg / m² (≥23 kg / m² for those of Asian origin) and ≤ 35 kg&#xD;
             / m² for screening.&#xD;
&#xD;
          3. Stable weight (maximum variation of approximately 5%) for at least 4 weeks prior to&#xD;
             screening.&#xD;
&#xD;
          4. Apt and willing to provide the written informed consent term and to comply with the&#xD;
             requirements of the study protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Clinically symptomatic gastrointestinal disease including, but not limited to,&#xD;
             inflammatory bowel disease.&#xD;
&#xD;
          2. History of gastric bypass, antrectomy, or resection of the small intestine.&#xD;
&#xD;
          3. History of chronic pancreatitis or acute idiopathic pancreatitis.&#xD;
&#xD;
          4. Myocardial infarction, coronary artery bypass grafting, post-transplant cardiomyopathy&#xD;
             or stroke in the last 6 months.&#xD;
&#xD;
          5. Any anomaly in clinical laboratory tests which may prevent safe participation in the&#xD;
             study.&#xD;
&#xD;
          6. Tumor diagnosed and / or treated (except basal cell skin cancer, cervical carcinoma in&#xD;
             situ, or prostate cancer in situ) within the past 5 years.&#xD;
&#xD;
          7. Hemoglobinopathy or chronic anemia known.&#xD;
&#xD;
          8. Donation of one unit (500 ml) or more of blood, significant loss of blood equivalent&#xD;
             to at least one unit of blood within the last 2 weeks or blood transfusion in the last&#xD;
             8 weeks.&#xD;
&#xD;
          9. Any concomitant medical condition / disorder which, in the investigator's opinion, is&#xD;
             likely to:&#xD;
&#xD;
               -  Will interfere with the patient's ability to complete the entire study period or&#xD;
                  participate in all study activities;&#xD;
&#xD;
               -  Require, during the study, the administration of a treatment that may affect the&#xD;
                  interpretation of the efficacy and safety data.&#xD;
&#xD;
         10. Treatment with any oral antidiabetic medicinal product and / or herbal preparations /&#xD;
             non-prescription medicines that may affect glycemic control within 12 weeks prior to&#xD;
             screening.&#xD;
&#xD;
         11. Chronic treatment with oral or parenteral corticosteroids (&gt; 7 consecutive days of&#xD;
             treatment) within 4 weeks prior to screening.&#xD;
&#xD;
         12. Treatment with weight-reducing agents (eg, orlistat, sibutramine, topiramate,&#xD;
             bupropion) within the last 12 weeks prior to screening.&#xD;
&#xD;
         13. History of unstable hypertension (&gt; 170/105 mmHg) in the last 12 weeks prior to&#xD;
             screening.&#xD;
&#xD;
         14. Treatment with a lipid-lowering drug that has not been kept in a stable dose within&#xD;
             the last 8 weeks prior to screening.&#xD;
&#xD;
         15. Treatment with thyroid hormone that has not been kept in a stable dose in the last 12&#xD;
             weeks prior to screening.&#xD;
&#xD;
         16. Investigational drug use within 30 days or 5 half-lives (whichever is longer) prior to&#xD;
             screening unless guidelines from local health authorities require a longer period.&#xD;
&#xD;
         17. Any of the following laboratory abnormalities in screening:&#xD;
&#xD;
               -  Alanine aminotransferase (ALT) and / or Aspartate aminotransferase (AST) 3 times&#xD;
                  the upper limit of normality;&#xD;
&#xD;
               -  Glomerular filtration estimated by the equation kidney disease ≤ 60 ml per min by&#xD;
                  1.73 m².&#xD;
&#xD;
               -  Fasting triglycerides &gt; 5.6 mmol / L;&#xD;
&#xD;
               -  Thyroid stimulating hormone (TSH) outside normal range.&#xD;
&#xD;
         18. History of substance abuse (including alcohol) within the last year.&#xD;
&#xD;
         19. Women with potential to become pregnant and / or who are using local or systemic&#xD;
             hormonal contraceptive method; Women in the follicular phase of the menstrual cycle&#xD;
             and also pregnant and lactating women.&#xD;
&#xD;
         20. Potentially unreliable patients and those considered by the Investigator as unsuitable&#xD;
             for the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fernando Gerchman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Rio Grande do Sul</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fernando Gerchman, MD</last_name>
    <phone>+55 51 99993-3491</phone>
    <email>fgerchman@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ana Duarte, RND</last_name>
    <phone>+55 51 98429-5548</phone>
    <email>nutrianacduarte@gmail.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Kahn SE, Prigeon RL, McCulloch DK, Boyko EJ, Bergman RN, Schwartz MW, Neifing JL, Ward WK, Beard JC, Palmer JP, et al. Quantification of the relationship between insulin sensitivity and beta-cell function in human subjects. Evidence for a hyperbolic function. Diabetes. 1993 Nov;42(11):1663-72. doi: 10.2337/diab.42.11.1663.</citation>
    <PMID>8405710</PMID>
  </reference>
  <reference>
    <citation>Johnston KL, Thomas EL, Bell JD, Frost GS, Robertson MD. Resistant starch improves insulin sensitivity in metabolic syndrome. Diabet Med. 2010 Apr;27(4):391-7. doi: 10.1111/j.1464-5491.2010.02923.x. Erratum In: Diabet Med. 2015 Feb;32(2):288.</citation>
    <PMID>20536509</PMID>
  </reference>
  <reference>
    <citation>Asp NG, van Amelsvoort JM, Hautvast JG. Nutritional implications of resistant starch. Nutr Res Rev. 1996 Jan;9(1):1-31. doi: 10.1079/NRR19960004. No abstract available.</citation>
    <PMID>19094263</PMID>
  </reference>
  <reference>
    <citation>Higgins JA. Resistant starch: metabolic effects and potential health benefits. J AOAC Int. 2004 May-Jun;87(3):761-8.</citation>
    <PMID>15287677</PMID>
  </reference>
  <reference>
    <citation>Maki KC, Carson ML, Miller MP, Turowski M, Bell M, Wilder DM, Reeves MS. High-viscosity hydroxypropylmethylcellulose blunts postprandial glucose and insulin responses. Diabetes Care. 2007 May;30(5):1039-43. doi: 10.2337/dc06-2344. Epub 2007 Jan 26. Erratum In: Diabetes Care. 2008 Sep;31(9): 1922-3.</citation>
    <PMID>17259476</PMID>
  </reference>
  <reference>
    <citation>Moulin CC, Tiskievicz F, Zelmanovitz T, de Oliveira J, Azevedo MJ, Gross JL. Use of weighed diet records in the evaluation of diets with different protein contents in patients with type 2 diabetes. Am J Clin Nutr. 1998 May;67(5):853-7. doi: 10.1093/ajcn/67.5.853.</citation>
    <PMID>9583841</PMID>
  </reference>
  <reference>
    <citation>Kahn SE, Hull RL, Utzschneider KM. Mechanisms linking obesity to insulin resistance and type 2 diabetes. Nature. 2006 Dec 14;444(7121):840-6. doi: 10.1038/nature05482.</citation>
    <PMID>17167471</PMID>
  </reference>
  <reference>
    <citation>Kahn SE, Zraika S, Utzschneider KM, Hull RL. The beta cell lesion in type 2 diabetes: there has to be a primary functional abnormality. Diabetologia. 2009 Jun;52(6):1003-12. doi: 10.1007/s00125-009-1321-z. Epub 2009 Mar 27.</citation>
    <PMID>19326096</PMID>
  </reference>
  <reference>
    <citation>Perreault L, Pan Q, Mather KJ, Watson KE, Hamman RF, Kahn SE; Diabetes Prevention Program Research Group. Effect of regression from prediabetes to normal glucose regulation on long-term reduction in diabetes risk: results from the Diabetes Prevention Program Outcomes Study. Lancet. 2012 Jun 16;379(9833):2243-51. doi: 10.1016/S0140-6736(12)60525-X. Epub 2012 Jun 9.</citation>
    <PMID>22683134</PMID>
  </reference>
  <reference>
    <citation>Tabak AG, Herder C, Rathmann W, Brunner EJ, Kivimaki M. Prediabetes: a high-risk state for diabetes development. Lancet. 2012 Jun 16;379(9833):2279-90. doi: 10.1016/S0140-6736(12)60283-9. Epub 2012 Jun 9.</citation>
    <PMID>22683128</PMID>
  </reference>
  <reference>
    <citation>Englyst HN, Kingman SM, Cummings JH. Classification and measurement of nutritionally important starch fractions. Eur J Clin Nutr. 1992 Oct;46 Suppl 2:S33-50.</citation>
    <PMID>1330528</PMID>
  </reference>
  <reference>
    <citation>Murphy MM, Douglass JS, Birkett A. Resistant starch intakes in the United States. J Am Diet Assoc. 2008 Jan;108(1):67-78. doi: 10.1016/j.jada.2007.10.012. Erratum In: J Am Diet Assoc. 2008 May;108(5):890.</citation>
    <PMID>18155991</PMID>
  </reference>
  <reference>
    <citation>Robertson MD, Wright JW, Loizon E, Debard C, Vidal H, Shojaee-Moradie F, Russell-Jones D, Umpleby AM. Insulin-sensitizing effects on muscle and adipose tissue after dietary fiber intake in men and women with metabolic syndrome. J Clin Endocrinol Metab. 2012 Sep;97(9):3326-32. doi: 10.1210/jc.2012-1513. Epub 2012 Jun 28.</citation>
    <PMID>22745235</PMID>
  </reference>
  <reference>
    <citation>DeFronzo RA, Tobin JD, Andres R. Glucose clamp technique: a method for quantifying insulin secretion and resistance. Am J Physiol. 1979 Sep;237(3):E214-23. doi: 10.1152/ajpendo.1979.237.3.E214.</citation>
    <PMID>382871</PMID>
  </reference>
  <reference>
    <citation>Sjaarda L, Lee S, Tfayli H, Bacha F, Bertolet M, Arslanian S. Measuring beta-cell function relative to insulin sensitivity in youth: does the hyperglycemic clamp suffice? Diabetes Care. 2013 Jun;36(6):1607-12. doi: 10.2337/dc12-1508. Epub 2012 Dec 28.</citation>
    <PMID>23275361</PMID>
  </reference>
  <reference>
    <citation>Tarini J, Wolever TM. The fermentable fibre inulin increases postprandial serum short-chain fatty acids and reduces free-fatty acids and ghrelin in healthy subjects. Appl Physiol Nutr Metab. 2010 Feb;35(1):9-16. doi: 10.1139/H09-119.</citation>
    <PMID>20130660</PMID>
  </reference>
  <reference>
    <citation>Anderson JW, Davidson MH, Blonde L, Brown WV, Howard WJ, Ginsberg H, Allgood LD, Weingand KW. Long-term cholesterol-lowering effects of psyllium as an adjunct to diet therapy in the treatment of hypercholesterolemia. Am J Clin Nutr. 2000 Jun;71(6):1433-8. doi: 10.1093/ajcn/71.6.1433.</citation>
    <PMID>10837282</PMID>
  </reference>
  <reference>
    <citation>Menezes EW, Tadini CC, Tribess TB, Zuleta A, Binaghi J, Pak N, Vera G, Dan MC, Bertolini AC, Cordenunsi BR, Lajolo FM. Chemical composition and nutritional value of unripe banana flour (Musa acuminata, var. Nanicao). Plant Foods Hum Nutr. 2011 Sep;66(3):231-7. doi: 10.1007/s11130-011-0238-0.</citation>
    <PMID>21732181</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>June 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>July 13, 2018</last_update_submitted>
  <last_update_submitted_qc>July 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prediabetes</keyword>
  <keyword>resistant starch</keyword>
  <keyword>insulin sensitivity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Prediabetic State</mesh_term>
    <mesh_term>Glucose Intolerance</mesh_term>
    <mesh_term>Hypersensitivity</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/NCT03294915
org study id: 15-0155
nct id: NCT03294915
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To compare the use supplementation based on green banana flour versus placebo in the insulin
      sensitivity on individuals who have prediabetes.
In order to evaluate whether supplementation with green banana flour may improve insulin
      sensitivity of individuals with prediabetes, volunteers will be recruited by advertising on
      the web page of Hospital de Clinical de Porto Alegre. After screening and selection, they
      will be submitted to a clinical, laboratory and nutritional standard evaluation, assessment
      of physical activity and body fat composition.The laboratory evaluation will include the oral
      glucose tolerance test (OGGT 75g), lipid profile, insulin, C-peptide, glycated hemoglobin and
      glycated albumin. Insulin sensitivity and beta-cell function will be assessed by the
      hyperglycemic CLAMP before and after the intervention.Interim statistical analysis will be
      performed at the end of the participation of ten study volunteers.

      Subjects will receive green banana flour or placebo for four weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Insulin sensitivity
time frame: 4 weeks
description: Insulin sensitivity compared to the baseline visit measured by hyperglycemia clamp
measure: Hormonal changes
time frame: 4 weeks
description: Alteration of hormones that affect glucose metabolism, such as peptide C
measure: Change in lipid profile
time frame: 4 weeks
description: Alteration of total cholesterol, HDL-cholesterol and triglycerides
measure: Change total body fat
time frame: 4 weeks
description: Change total body fat will be compared before and after the intervention by means of bioimpedance
measure: Beta cell function
time frame: 4 weeks
description: Beta cell function (first and second phase of insulin secretion) will be measured by hyperglycemic clamp
measure: Glycemic control
time frame: 4 weeks
description: Measured by hemoglobin glycated
arm group label: Resistant Starch
arm group type: Active Comparator
description: Green banana flour
arm group label: Placebo
arm group type: Placebo Comparator
description: Maltodextrin, cellulose and guar gum
intervention type: Dietary Supplement
intervention name: Resistant Starch
description: Addition of 42g per day of green banana flour (10g / day resistant starch) to the usual diet of study participants
arm group label: Resistant Starch
intervention type: Dietary Supplement
intervention name: Placebo
description: Addition of 42g per day of mixture of guar gum, maltodextrin and cellulose to the usual diet of study participants
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fernando Gerchman, MD
role: Principal Investigator
affiliation: Federal University of Rio Grande do Sul
last name: Fernando Gerchman, MD
phone: +55 51 99993-3491
email: fgerchman@gmail.com
last name: Ana Duarte, RND
phone: +55 51 98429-5548
email: nutrianacduarte@gmail.com
citation: Kahn SE, Prigeon RL, McCulloch DK, Boyko EJ, Bergman RN, Schwartz MW, Neifing JL, Ward WK, Beard JC, Palmer JP, et al. Quantification of the relationship between insulin sensitivity and beta-cell function in human subjects. Evidence for a hyperbolic function. Diabetes. 1993 Nov;42(11):1663-72. doi: 10.2337/diab.42.11.1663.
PMID: 8405710
citation: Johnston KL, Thomas EL, Bell JD, Frost GS, Robertson MD. Resistant starch improves insulin sensitivity in metabolic syndrome. Diabet Med. 2010 Apr;27(4):391-7. doi: 10.1111/j.1464-5491.2010.02923.x. Erratum In: Diabet Med. 2015 Feb;32(2):288.
PMID: 20536509
citation: Asp NG, van Amelsvoort JM, Hautvast JG. Nutritional implications of resistant starch. Nutr Res Rev. 1996 Jan;9(1):1-31. doi: 10.1079/NRR19960004. No abstract available.
PMID: 19094263
citation: Higgins JA. Resistant starch: metabolic effects and potential health benefits. J AOAC Int. 2004 May-Jun;87(3):761-8.
PMID: 15287677
citation: Maki KC, Carson ML, Miller MP, Turowski M, Bell M, Wilder DM, Reeves MS. High-viscosity hydroxypropylmethylcellulose blunts postprandial glucose and insulin responses. Diabetes Care. 2007 May;30(5):1039-43. doi: 10.2337/dc06-2344. Epub 2007 Jan 26. Erratum In: Diabetes Care. 2008 Sep;31(9): 1922-3.
PMID: 17259476
citation: Moulin CC, Tiskievicz F, Zelmanovitz T, de Oliveira J, Azevedo MJ, Gross JL. Use of weighed diet records in the evaluation of diets with different protein contents in patients with type 2 diabetes. Am J Clin Nutr. 1998 May;67(5):853-7. doi: 10.1093/ajcn/67.5.853.
PMID: 9583841
citation: Kahn SE, Hull RL, Utzschneider KM. Mechanisms linking obesity to insulin resistance and type 2 diabetes. Nature. 2006 Dec 14;444(7121):840-6. doi: 10.1038/nature05482.
PMID: 17167471
citation: Kahn SE, Zraika S, Utzschneider KM, Hull RL. The beta cell lesion in type 2 diabetes: there has to be a primary functional abnormality. Diabetologia. 2009 Jun;52(6):1003-12. doi: 10.1007/s00125-009-1321-z. Epub 2009 Mar 27.
PMID: 19326096
citation: Perreault L, Pan Q, Mather KJ, Watson KE, Hamman RF, Kahn SE; Diabetes Prevention Program Research Group. Effect of regression from prediabetes to normal glucose regulation on long-term reduction in diabetes risk: results from the Diabetes Prevention Program Outcomes Study. Lancet. 2012 Jun 16;379(9833):2243-51. doi: 10.1016/S0140-6736(12)60525-X. Epub 2012 Jun 9.
PMID: 22683134
citation: Tabak AG, Herder C, Rathmann W, Brunner EJ, Kivimaki M. Prediabetes: a high-risk state for diabetes development. Lancet. 2012 Jun 16;379(9833):2279-90. doi: 10.1016/S0140-6736(12)60283-9. Epub 2012 Jun 9.
PMID: 22683128
citation: Englyst HN, Kingman SM, Cummings JH. Classification and measurement of nutritionally important starch fractions. Eur J Clin Nutr. 1992 Oct;46 Suppl 2:S33-50.
PMID: 1330528
citation: Murphy MM, Douglass JS, Birkett A. Resistant starch intakes in the United States. J Am Diet Assoc. 2008 Jan;108(1):67-78. doi: 10.1016/j.jada.2007.10.012. Erratum In: J Am Diet Assoc. 2008 May;108(5):890.
PMID: 18155991
citation: Robertson MD, Wright JW, Loizon E, Debard C, Vidal H, Shojaee-Moradie F, Russell-Jones D, Umpleby AM. Insulin-sensitizing effects on muscle and adipose tissue after dietary fiber intake in men and women with metabolic syndrome. J Clin Endocrinol Metab. 2012 Sep;97(9):3326-32. doi: 10.1210/jc.2012-1513. Epub 2012 Jun 28.
PMID: 22745235
citation: DeFronzo RA, Tobin JD, Andres R. Glucose clamp technique: a method for quantifying insulin secretion and resistance. Am J Physiol. 1979 Sep;237(3):E214-23. doi: 10.1152/ajpendo.1979.237.3.E214.
PMID: 382871
citation: Sjaarda L, Lee S, Tfayli H, Bacha F, Bertolet M, Arslanian S. Measuring beta-cell function relative to insulin sensitivity in youth: does the hyperglycemic clamp suffice? Diabetes Care. 2013 Jun;36(6):1607-12. doi: 10.2337/dc12-1508. Epub 2012 Dec 28.
PMID: 23275361
citation: Tarini J, Wolever TM. The fermentable fibre inulin increases postprandial serum short-chain fatty acids and reduces free-fatty acids and ghrelin in healthy subjects. Appl Physiol Nutr Metab. 2010 Feb;35(1):9-16. doi: 10.1139/H09-119.
PMID: 20130660
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PMID: 21732181
responsible party type: Sponsor
mesh term: Insulin Resistance
mesh term: Prediabetic State
mesh term: Glucose Intolerance
mesh term: Hypersensitivity
sharing ipd: No