Effects of Prebiotics on GLP-1 in Type 2 Diabetes

NCT ID: NCT02569684

Last Updated: 2020-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm A

Prebiotic fibers: Oligofructose and inulin

Group Type ACTIVE_COMPARATOR

Prebiotic fibers: oligofructose and inulin

Intervention Type DIETARY_SUPPLEMENT

Arm B

Maltodextrin

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Prebiotic fibers: oligofructose and inulin

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian Diabetes Association

OTHER

Sponsor Role collaborator

Norwegian Extra Foundation for Health and Rehabilitation

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anne-Marie Aas

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne-Marie Aas, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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Birkeland E, Bamigbetan WA, Molven KD, Thorsby PM, Gulseth HL, Aas AM, Dahl C. Can supplements with prebiotic fibres positively influence bone health in type 2 diabetes? Insights from a randomised controlled crossover trial. Arch Osteoporos. 2025 Jun 5;20(1):71. doi: 10.1007/s11657-025-01556-x.

Reference Type DERIVED
PMID: 40471453 (View on PubMed)

Birkeland E, Gharagozlian S, Gulseth HL, Birkeland KI, Hartmann B, Holst JJ, Holst R, Aas AM. Effects of prebiotics on postprandial GLP-1, GLP-2 and glucose regulation in patients with type 2 diabetes: A randomised, double-blind, placebo-controlled crossover trial. Diabet Med. 2021 Oct;38(10):e14657. doi: 10.1111/dme.14657. Epub 2021 Aug 7.

Reference Type DERIVED
PMID: 34297363 (View on PubMed)

Birkeland E, Gharagozlian S, Birkeland KI, Valeur J, Mage I, Rud I, Aas AM. Prebiotic effect of inulin-type fructans on faecal microbiota and short-chain fatty acids in type 2 diabetes: a randomised controlled trial. Eur J Nutr. 2020 Oct;59(7):3325-3338. doi: 10.1007/s00394-020-02282-5. Epub 2020 May 21.

Reference Type DERIVED
PMID: 32440730 (View on PubMed)

Other Identifiers

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1180 REK

Identifier Type: -

Identifier Source: org_study_id

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