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Trial · Interventional

Status unknownPhase 4Registry data

Exenatide and Brown Adipose Tissue

Short name exe01

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
24 participants (estimated)
Sponsor
Ingrid Jazet · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Netherlands

Start
Aug 2016
Primary completion
Jun 2018 (estimated)
Completion
Not stated
First posted
26 Dec 2016 (estimated)
Last update posted
26 Dec 2016 (estimated)
Conditions
Obesity

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2016201720182019
  1. Ph 4

    exe01

    NCT03002675

    Aug 2016 to est. Jun 2018 (primary)

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The obesity epidemic has led to a enormous increase in the prevalence of type 2 diabetes mellitus (T2D), dyslipidemia and cardiovascular events. Particularly South Asians, who comprise 1/5 of the world population, are at increased risk of developing a disadvantageous metabolic phenotype and these diseases. Moreover, T2D occurs at a younger age and at a lower BMI when compared to white Caucasians. Recent research has shown that South Asians not only have a lower energy expenditure than their Caucasian counterparts, but also less active brown adipose tissue (BAT). For some time, it has been known that adult humans have active BAT. This metabolic tissue produces heat by combusting triglycerides, in contrast to white adipose tissue, which stores this form of energy. It has been shown that activation of BAT has a positive effect on whole body metabolism, via increasing energy expenditure and improving glucose- and lipid metabolism. For this matter, BAT has been proposed as a major key player in energy homeostasis, which may be implemented in the current combat against the obesity epidemic. Aside from cold exposure, more research focuses on pharmacological activation of BAT. Glucagon-like peptide 1 (GLP-1) is an incretin hormone which is produced by intestinal L-cells and upon food intake stimulates insulin secretion by pancreatic beta cells. The GLP-1 analogue Exenatide is a currently much used antidiabetic drug to reduce hyperglycemia via this aforementioned mechanism. Beyond its blood glucose-improving effects, Exenatide has also shown to lower body weight and improve dyslipidemia in T2D patients. Elucidation of the underlying mechanism of these beneficial effects is highly relevant. Recent preclinical research in our group has shown that central activation of the GLP-1 receptor through exenatide increases BAT activity and thereby contributes to weight loss and improvement of dyslipidemia. The aim of this research project is to investigate whether exenatide is also able to activate BAT and increase resting energy expenditure, thereby improving glucose- and lipid metabolism and reducing fat mass and body weight in humans. Moreover, the investigators aim to validate the MRI scan as a novel way to measure BAT activity. The investigators hope that these forthcoming findings lead to the discovery of new treatment strategies against obesity.

Interventions

  • BydureonDrug

Arms1

  • Experimental

    exenatide

    Participants will receive exenatide (Bydureon, 2mg s.c. 1x/wk, AstraZeneca) during 12 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The effect of exenatide on BAT activity and energy expenditure in healthy young South Asian compared to white Caucasian men

    Time frame · End of the study, up to 21 months

Secondary outcomes(1)
  1. Visualisation of BAT as measured with MRI scan compared to FDG-PET CT

    Time frame · End of the study, up to 21 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2020

10 results

Twelve weeks of exenatide treatment increases [18F]fluorodeoxyglucose uptake by brown adipose tissue without affecting oxidative resting energy expenditure in nondiabetic males.

Janssen et al. 2020Metabolism: clinical and experimentalcited by 47

PMID 31982480DOI 10.1016/j.metabol.2020.154167PUB-31982480

CC BY10 results

Eligibility

Who could join, as posted.

Sex
Male
Age
from 20 Years up to 30 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Dutch South Asian or white Caucasian male, 20-30 years * BMI ≥ 18 and ≤ 25 kg/m2 * Good general health Exclusion Criteria: * BMI \> 25 kg/m2 or \< 18 kg/m2 * Use of medication known to influence glucose and/or lipid metabolism or brown fat activity (e.g. beta blockers) * Any significant chronic disease * Renal, hepatic or endocrine disease * Smoking * Participation in an intensive weight-loss program or vigorous exercise program during the last year before the start of the study * Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year * Contraindications for undergoing an MRI scan: * Presence of non-MR safe metal implants or objects in the body. * Pacemaker, neurostimulator, hydrocephalus pump, drug pump, non-removable hearing aid, large recent tattoos. * Claustrophobia * Tinnitus or hyperacusis

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