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

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ClinicalTrials.gov Identifier: NCT02796950
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date  ICMJE May 27, 2016
First Posted Date  ICMJE June 13, 2016
Last Update Posted Date May 8, 2018
Study Start Date  ICMJE June 2016
Actual Primary Completion Date January 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2016)
Levels of GLP-1 in plasma [ Time Frame: 9 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02796950 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2016)
  • Lipolytic activity in adipose tissue by measuring FFA (free fatty acid) levels [ Time Frame: 9 months ]
  • Insulin sensitivity by measuring blood glucose after an OGTT [ Time Frame: 5 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 7, 2016)
  • Insulin secretion by measuring levels of insulin and c-peptid [ Time Frame: 9 months ]
  • Secretion of the hormones ghrelin, leptin and GIP (gastric inhibitory polypeptide) by measuring hormone levels in plasma [ Time Frame: 9 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effect of Acipimox on GLP (Glucagon-like Peptide)-1 Secretion
Official Title  ICMJE The Effect of Acipimox on GLP-1 Secretion in Healthy Subjects: a Pilot Study
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Diabetes Mellitus Type 2
Intervention  ICMJE Drug: Acipimox
P.o. administration of 250 mg acipimox
Other Name: Olbetam
Study Arms  ICMJE
  • Experimental: Acipimox
    Administration of acipimox 250 mg p.o.
    Intervention: Drug: Acipimox
  • No Intervention: Control
    No intervention.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 7, 2016)
8
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 20, 2017
Actual Primary Completion Date January 20, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult men
  • Healthy
  • BMI 25-35

Exclusion Criteria:

  • Known DM2
  • Receiving hypolipidemic drugs
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02796950
Other Study ID Numbers  ICMJE GLP-1-16-02-261-16
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jens Otto L Jørgensen, Professor University of Aarhus
PRS Account University of Aarhus
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP