The Role of Metformin and Colesevelam in Human GLP-1 Secretion

NCT ID: NCT02050074

Last Updated: 2014-10-07

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

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-09-30

Brief Summary

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Our primary hypothesis is that bile acid sequestrant colesevelam and the antidiabetic drug metformin potentiates the secretion of the gut hormone glucagon-like peptide 1 (GLP-1).

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Colesevelam

Group Type EXPERIMENTAL

Colesevelam

Intervention Type DRUG

Metformin

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

Colesevelam + exendin (9-39)

Group Type EXPERIMENTAL

Colesevelam

Intervention Type DRUG

Metformin + exendin (9-39)

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Placebo + + exendin (9-39)

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

Interventions

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Colesevelam

Intervention Type DRUG

Metformin

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Normal hemoglobin
* BMI \> 23kg/m2
* HbA1c \<9 %
* Informed concent

Exclusion Criteria

* Liver disease ( aspartate aminotransferase/alanine aminotransferase \>2 × reference value)
* Chronic intestinal disease
* History of liver and / or gallbladder disease
* Nephropathy (se-creatinine \>110 µM and / or albuminuria)
* Insulin or GLP-1-based antidiabetic treatment
* History of cholecystectomy or surgical resection of bowel segment
* BMI \<23kg/m2 or BMI \>35 kg/m2
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Morten Hansen

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Diabetes Research Division, Department of Medicine, Gentofte Hospital

Hellerup, Copenhagen, Denmark

Site Status

Countries

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Denmark

References

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Bahne E, Sun EWL, Young RL, Hansen M, Sonne DP, Hansen JS, Rohde U, Liou AP, Jackson ML, de Fontgalland D, Rabbitt P, Hollington P, Sposato L, Due S, Wattchow DA, Rehfeld JF, Holst JJ, Keating DJ, Vilsboll T, Knop FK. Metformin-induced glucagon-like peptide-1 secretion contributes to the actions of metformin in type 2 diabetes. JCI Insight. 2018 Dec 6;3(23):e93936. doi: 10.1172/jci.insight.93936.

Reference Type DERIVED
PMID: 30518693 (View on PubMed)

Other Identifiers

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H-1-2013-010

Identifier Type: -

Identifier Source: org_study_id

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