Lipolytic Effects of GH in Human Subjects in Vivo

Not Applicable

Completed

• Conditions: Metabolic Diseases; Growth Hormone Treatment
• Interventions: Drug: Pegisomant; Drug: Growth Hormone

• Registration Number: NCT02782221
• Lead Sponsor: University of Aarhus

Brief Summary

Growth hormone (GH) induces fat metabolism. The mechanisms underlying the fat metabolizing effects of GH remain elusive. However, it is known that insulin suppresses fat metabolism, and GH inhibits the expression of certain insulin-dependent signaling proteins. We therefore hypothesize that the fat metabolizing effects of GH depend on abrogation of insulin-dependent signaling pathways.

In order to investigate the fat metabolizing effects of GH, we'll analyze consecutive adipose tissue biopsies taken after GH exposure and GH blocking, respectively.

Knowledge of the effects of growth hormone and fat metabolism can in shot-sight as well as in long-sight have great importance for the understanding of growth disorders from overweight and type 2 diabetes to malnutrition and eating disorders.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-05-20
• Study First Posted: 2016-05-25
• Study Start: 2016-05-30
• Primary Completion: 2016-09-22
• Study Completion: 2017-01-15
• Status Verified: 2017-10
• Last Update Submitted: 2020-03-25
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 9

Inclusion Criteria

• healthy males
• no medication
• BMI 28-35

Exclusion Criteria

• known diseases
• regular medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Pegisomant	Subjects are receiving pegvisomant to block the action of growth hormone
Growth hormone	Growth Hormone	Subjects are receiving growth hormone

Primary Outcome Measures

Name	Time	Method
Lipolytic activity measured as area under the curve (AUC) for FFA (blood sample).	1 year

Secondary Outcome Measures

Name	Time	Method
Substrate metabolism as measured by indirect calorimetry	3 months
GH signaling proteins in adipose tissue measured by western blotting	1,5 years
Intracellular lipolytic activity measured by an ATGL assay	1 year
GH signaling gene targets in adipose tissue measured by qPCR	1,5 years

Trial Locations

Locations (1)

University Hospital of Aarhus; 🇩🇰 Aarhus, Denmark