Effects of Prebiotics on GLP-1 in Type 2 Diabetes

• Sponsor: Oslo University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02569684
• Collaborator: Norwegian Diabetes Association (Other), Norwegian Extra Foundation for Health and Rehabilitation (Other)
• Enrollment: 37
• Location: 1
• Arms: 2
• Actual Duration (Months): 50
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• 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: Oct 1, 2015
• Actual Primary Completion Date: Jan 1, 2018
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

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

Outcome Measures

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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oslo University Hospital	Oslo		Norway	0424

Sponsors and Collaborators

• Oslo University Hospital
• Norwegian Diabetes Association
• Norwegian Extra Foundation for Health and Rehabilitation

Investigators

• Principal Investigator: Anne-Marie Aas, PhD, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anne-Marie Aas, Associate professor, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT02569684
• Other Study ID Numbers: 1180 REK
• First Posted: Oct 7, 2015
• Last Update Posted: Sep 16, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Sep 16, 2020