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NCT Number: NCT02796950

The Effect of Acipimox on GLP (Glucagon-like Peptide)-1 Secretion

Glucagon like peptide 1 is produced in enteroendocrine L cells in the small intestine stimulated by peroral food intake. GLP-1 induces insulin secretion, and analogues are used in the treatment of DM2 (type 2 diabetes mellitus). Recently it was found, that levels of GLP-1 are increased in response to acipimox. The hypothesis is that G protein coupled receptors on enteroendocrine L cells bind acipimox and thereby induce GLP-1 secretion.

In a controlled, open, randomized experiment, eight healthy, overweight men will be studied on an intervention day, where they receive acipimox, and on a control day. The study day includes an OGTT (oral glucose tolerance test), blood samples before and after the OGTT and a biopsy from adipose tissue.

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Key information

Conditions

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

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Aarhus

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult men
  • Healthy
  • BMI 25-35

Exclusion criteria

  • Known DM2
  • Receiving hypolipidemic drugs

Treatment and study plan

Acipimox

Drug

P.o. administration of 250 mg acipimox

Other names: Olbetam

Primary outcomes

  1. Levels of GLP-1 in plasma

    Time frame: 9 months

Secondary outcomes

  1. Lipolytic activity in adipose tissue by measuring FFA (free fatty acid) levels

    Time frame: 9 months

  2. Insulin sensitivity by measuring blood glucose after an OGTT

    Time frame: 5 months

Other outcomes

  1. Insulin secretion by measuring levels of insulin and c-peptid

    Time frame: 9 months

  2. Secretion of the hormones ghrelin, leptin and GIP (gastric inhibitory polypeptide) by measuring hormone levels in plasma

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

The Effect of Acipimox on GLP-1 Secretion in Healthy Subjects: a Pilot Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 13, 2016
Registry last updated
May 8, 2018

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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