Back to resultsThe Effect of Acipimox on GLP (Glucagon-like Peptide)-1 Secretion
Primary Purpose
Diabetes Mellitus Type 2
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Acipimox
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus Type 2 focused on measuring Acipimox, GLP-1, Insulin secretion
Eligibility Criteria
Inclusion Criteria:
- Adult men
- Healthy
- BMI 25-35
Exclusion Criteria:
- Known DM2
- Receiving hypolipidemic drugs
Sites / Locations
- University Hospital of Aarhus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Acipimox
Control
Arm Description
Administration of acipimox 250 mg p.o.
No intervention.
Outcomes
Primary Outcome Measures
Levels of GLP-1 in plasma
Secondary Outcome Measures
Lipolytic activity in adipose tissue by measuring FFA (free fatty acid) levels
Insulin sensitivity by measuring blood glucose after an OGTT
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02796950
Brief Title
The Effect of Acipimox on GLP (Glucagon-like Peptide)-1 Secretion
Official Title
The Effect of Acipimox on GLP-1 Secretion in Healthy Subjects: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
January 20, 2017 (Actual)
Study Completion Date
January 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2
Keywords
Acipimox, GLP-1, Insulin secretion
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acipimox
Arm Type
Experimental
Arm Description
Administration of acipimox 250 mg p.o.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention.
Intervention Type
Drug
Intervention Name(s)
Acipimox
Other Intervention Name(s)
Olbetam
Intervention Description
P.o. administration of 250 mg acipimox
Primary Outcome Measure Information:
Title
Levels of GLP-1 in plasma
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Lipolytic activity in adipose tissue by measuring FFA (free fatty acid) levels
Time Frame
9 months
Title
Insulin sensitivity by measuring blood glucose after an OGTT
Time Frame
5 months
Other Pre-specified Outcome Measures:
Title
Insulin secretion by measuring levels of insulin and c-peptid
Time Frame
9 months
Title
Secretion of the hormones ghrelin, leptin and GIP (gastric inhibitory polypeptide) by measuring hormone levels in plasma
Time Frame
9 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult men
Healthy
BMI 25-35
Exclusion Criteria:
Known DM2
Receiving hypolipidemic drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Otto L Jørgensen, Professor
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Aarhus
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26885360
Citation
Pais R, Gribble FM, Reimann F. Stimulation of incretin secreting cells. Ther Adv Endocrinol Metab. 2016 Feb;7(1):24-42. doi: 10.1177/2042018815618177.
Results Reference
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PubMed Identifier
26106933
Citation
Iepsen EW, Torekov SS, Holst JJ. Liraglutide for Type 2 diabetes and obesity: a 2015 update. Expert Rev Cardiovasc Ther. 2015;13(7):753-67. doi: 10.1586/14779072.2015.1054810.
Results Reference
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PubMed Identifier
12563315
Citation
Tunaru S, Kero J, Schaub A, Wufka C, Blaukat A, Pfeffer K, Offermanns S. PUMA-G and HM74 are receptors for nicotinic acid and mediate its anti-lipolytic effect. Nat Med. 2003 Mar;9(3):352-5. doi: 10.1038/nm824. Epub 2003 Feb 3.
Results Reference
background
PubMed Identifier
24140022
Citation
Newman JC, Verdin E. Ketone bodies as signaling metabolites. Trends Endocrinol Metab. 2014 Jan;25(1):42-52. doi: 10.1016/j.tem.2013.09.002. Epub 2013 Oct 18.
Results Reference
background
PubMed Identifier
1317767
Citation
Fulcher GR, Walker M, Catalano C, Farrer M, Alberti KG. Acute metabolic and hormonal responses to the inhibition of lipolysis in non-obese patients with non-insulin-dependent (type 2) diabetes mellitus: effects of acipimox. Clin Sci (Lond). 1992 May;82(5):565-71. doi: 10.1042/cs0820565.
Results Reference
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The Effect of Acipimox on GLP (Glucagon-like Peptide)-1 Secretion
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