NCT02796950

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 13, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2017

Completed
Last Updated

May 8, 2018

Status Verified

October 1, 2017

Enrollment Period

8 months

First QC Date

May 27, 2016

Last Update Submit

May 2, 2018

Conditions

Diabetes Mellitus Type 2

Keywords

AcipimoxGLP-1Insulin secretion

Outcome Measures

Primary Outcomes (1)

  • Levels of GLP-1 in plasma

    9 months

Secondary Outcomes (2)

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

    9 months

  • Insulin sensitivity by measuring blood glucose after an OGTT

    5 months

Other Outcomes (2)

  • Insulin secretion by measuring levels of insulin and c-peptid

    9 months

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

    9 months

Study Arms (2)

Acipimox

EXPERIMENTAL

Administration of acipimox 250 mg p.o.

Drug: Acipimox

Control

NO INTERVENTION

No intervention.

Interventions

AcipimoxDRUG

P.o. administration of 250 mg acipimox

Also known as: Olbetam
Acipimox

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult men
  • Healthy
  • BMI 25-35

You may not qualify if:

  • Known DM2
  • Receiving hypolipidemic drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Aarhus

Aarhus, 8000, Denmark

Location

Related Publications (5)

  • 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.

    PMID: 26885360BACKGROUND

  • 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.

    PMID: 26106933BACKGROUND

  • 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.

    PMID: 12563315BACKGROUND

  • 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.

    PMID: 24140022BACKGROUND

  • 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.

    PMID: 1317767BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

acipimox

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jens Otto L Jørgensen, Professor

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2016

First Posted

June 13, 2016

Study Start

June 1, 2016

Primary Completion

January 20, 2017

Study Completion

January 20, 2017

Last Updated

May 8, 2018

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)