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OpenTrials
Completed

NCT Number: NCT02050074

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

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).

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Diabetes Research Division, Department of Medicine, Gentofte Hospital

Hellerup, Copenhagen, 2900, Denmark

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Colesevelam

Drug

metformin

Drug

Placebo

Other

Primary outcomes

  1. Change in the gut hormone glucagon-like peptide 1 (GLP-1)

    Time frame: 0-240 min

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Acronym: ColMetInc

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 30, 2014
Registry last updated
Oct 7, 2014

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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