Effects of Prebiotics on GLP-1 in Type 2 Diabetes

Diabetes Type 2 Clinical Trial

Official title:

Effects of Prebiotics on GLP-1 in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02569684
• Other study ID #: 1180 REK
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: December 2019

Study information

• Verified date: September 2020
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

Dietary Supplement:
• Prebiotic fibers: oligofructose and inulin

• Maltodextrin

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	Norwegian Diabetes Association, Norwegian Extra Foundation for Health and Rehabilitation

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in plasma GLP-1 in response to standardized test meal before and after six weeks of ingestion of prebiotic fibers or placebo	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.	six weeks