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

Diabetes Mellitus Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02796950
• Other study ID #: GLP-1-16-02-261-16
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: January 20, 2017

Study information

• Verified date: October 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 20, 2017
• Est. primary completion date: January 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• Adult men

• Healthy

• BMI 25-35

Exclusion Criteria:

• Known DM2

• Receiving hypolipidemic drugs

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Acipimox
P.o. administration of 250 mg acipimox

Locations

Country	Name	City	State
Denmark	University Hospital of Aarhus	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

References & Publications (5)

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. — View 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. Review. — View 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. Review. — View 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. Review. — View 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. Epub 2003 Feb 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Insulin secretion by measuring levels of insulin and c-peptid		9 months
Other	Secretion of the hormones ghrelin, leptin and GIP (gastric inhibitory polypeptide) by measuring hormone levels in plasma		9 months
Primary	Levels of GLP-1 in plasma		9 months
Secondary	Lipolytic activity in adipose tissue by measuring FFA (free fatty acid) levels		9 months
Secondary	Insulin sensitivity by measuring blood glucose after an OGTT		5 months