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Effects of Prebiotics on GLP-1 in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT02569684
Recruitment Status : Completed
First Posted : October 7, 2015
Last Update Posted : September 16, 2020
Sponsor:
Collaborators:
Norwegian Diabetes Association
Norwegian Extra Foundation for Health and Rehabilitation
Information provided by (Responsible Party):
Anne-Marie Aas, Oslo University Hospital

Brief Summary:
The aim of the study is to compare the effects of prebiotics versus placebo on blood concentrations of glucagon-like peptide-1 in subjects with diabetes type 2.

Condition or disease Intervention/treatment Phase
Diabetes Type 2 Dietary Supplement: Prebiotic fibers: oligofructose and inulin Dietary Supplement: Maltodextrin Not Applicable

Detailed Description:
We looked at 6 weeks supplementation with a prebiotic fibre mix of inulin and FOS. Cross over design compared to maltodextrin as placebo. Additional outcome measures: blood glucose, insulin, GLP-2, ghrelin, PYY and leptin after a standardized mixed meal test. Also measured changes in microbiota composition and SCFA in feces before and after intervention/placebo periods, and subjective measures of appetite.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Prebiotics on GLP-1 in Type 2 Diabetes
Actual Study Start Date : October 2015
Actual Primary Completion Date : January 2018
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm A
Prebiotic fibers: Oligofructose and inulin
Dietary Supplement: Prebiotic fibers: oligofructose and inulin
Placebo Comparator: Arm B
Maltodextrin
Dietary Supplement: Maltodextrin



Primary Outcome Measures :
  1. Changes in plasma GLP-1 in response to standardized test meal before and after six weeks of ingestion of prebiotic fibers or placebo [ Time Frame: six weeks ]
    The changes in GLP-1 response to either prebiotic fibers or placebo will be compared in a cross-over manner where the participants are their own controls. In between the intervention periods there will be a wash-out period of 4 weeks.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diabetes type 2
  • BMI 18,5 - 40
  • Not medicated with insulin, GLP-1 analogues or DPP4 inhibitors
  • Moderate intake of alcohol
  • Not excessive exercise
  • Less than 3 kg weight change the last two months
  • Intake of less than 30 g dietary fiber per day

Exclusion Criteria:

  • IBD
  • IBS
  • Coeliac disease
  • Have used antibiotics within the last two months
  • Have used supplements with prebiotics or probiotics the last two months
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569684


Locations
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Norway
Oslo University Hospital
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Norwegian Diabetes Association
Norwegian Extra Foundation for Health and Rehabilitation
Investigators
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Principal Investigator: Anne-Marie Aas, PhD Oslo University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anne-Marie Aas, Associate professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02569684    
Other Study ID Numbers: 1180 REK
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases