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Completed

NCT Number: NCT02569684

Effects of Prebiotics on GLP-1 in Type 2 Diabetes

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.

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Key information

Conditions

Diabetes Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, 0424, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prebiotic fibers: oligofructose and inulin

Dietary Supplement

Maltodextrin

Dietary Supplement

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Norwegian Diabetes Association
  • Norwegian Extra Foundation for Health and Rehabilitation

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Oct 7, 2015
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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