Trial · Interventional

Status unknownNot applicableRegistry data

Growth Hormone as a Model for Reversible Activation of Adipose Tissue Fibrosis

NCTNCT04998500Other id1-10-72-283-20

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Status unknown
Phase: Not applicable
Enrollment: 10 participants (estimated)
Sponsor: University of Aarhus · Other
Design: Randomized · Single masking
Countries: 1 country
Denmark
Start: 1 Aug 2021
Primary completion: 31 Dec 2023 (estimated)
Completion: 31 Dec 2023 (estimated)
First posted: 10 Aug 2021
Last update posted: 30 May 2023
Conditions: Fibrosis

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2021202220232024

N/A
Growth Hormone as a Model for Reversible Activation of Adipose Tissue Fibrosis
NCT04998500
1 Aug 2021 to est. 31 Dec 2023

Registry summary

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

Background: Adipose tissue fibrosis denotes excessive pathological accumulation of extracellular matrix (ECM) in adipose tissue and is a marker of dysfunction. Growth hormone (GH) activates adipose tissue lipolysis and stimulates collagen synthesis in lean tissues. Intriguingly, we have novel pilot data to suggest that GH excess (acromegaly) also induces reversible fibrosis in vivo and potently activates the expression of fibroblast activation protein alpha (FAPα). Hypothesis: GH induces adipose tissue fibrosis by increased FAPα expression together with proliferation and fibrogenic differentiation of fibro-adipogenic progenitor (FAP) cells. Aim: To unravel the mechanisms underlying GH-induced adipose tissue fibrosis with emphasis on FAPα expression and proliferation of FAP cells. Subjects and methods: In a single blinded, randomized, double-dummy crossover design, 10 adult, moderately overweight individuals will be subjected to one week of GH and GH receptor blockade (Pegvisomant). We will use single-cell technologies, fluorescence-activated cell sorting (FACS), RNA sequencing, and cell culture studies on adipose tissue samples, combined with in vivo assessment of adipose tissue turnover and metabolism. Perspectives: Understanding fibrosis formation in human models may identify new targets for treatment of obesity-associated disorders.

Interventions

Growth hormone, saline and GH receptor blockade (Pegvisomant)Biological

Arms2

Experimental
GH intervention - control intervention
Participants will receive daily subcutaneous injections of growth hormone for 7 days. Approximately 1-4 months later, the participants will receive daily subcutaneous injections of control intervention for 7 days consisting of saline and GH receptor blockade (Pegvisomant).
Experimental
Control intervention - GH intervention
Participants will receive daily subcutaneous injections of control intervention for 7 days consisting of saline and GH receptor blockade (Pegvisomant). Approximately 1-4 months later, the participants will receive daily subcutaneous injections of growth hormone for 7 days.

Primary outcomes3

Outcomes the sponsor listed as primary.

Fibro-adipogenic progenitor (FAP) cells
Time frame · Anticipated approximately 1-5 months
Registry description
Quantification of FAP cells in adipose tissue, and in vitro determination of proliferation and fibro-/adipogenic differentiation potential
Fibroblast activation protein (FAPα)
Time frame · Anticipated approximately 1-5 months
Registry description
FAPα concentration and activity in blood, and expression in adipose tissue
Adipose tissue fibrosis
Time frame · Anticipated approximately 1-5 months
Registry description
Markers of fibrosis in adipose tissue assessed by light microscopy and immunohistochemically, RNA sequencing and heavy water labeled connective tissue turnover

Secondary outcomes(4)

Circulating biomarkers of collagen turnover
Time frame · Anticipated approximately 1-5 months
Registry description
(PINP, PIIINP)
Protein turnover in muscle tissue
Time frame · Anticipated approximately 1-5 months
Registry description
Heavy water labeled protein and connective tissue turnover in muscle tissue to compare with protein turnover in adipose tissue
Metabolism and fatty acid turnover
Time frame · Anticipated approximately 1-5 months
Registry description
Whole body energy metabolism and fatty acid turnover (indirect calorimetry and palmitate tracer kinetics)
Temperature
Time frame · Anticipated approximately 1-5 months
Registry description
Temperature measurements

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

PubMed tag: none · 2010

1 result

GH and IGF1 levels are positively associated with musculotendinous collagen expression: experiments in acromegalic and GH deficiency patients.

Doessing et al. 2010European journal of endocrinologycited by 43

PMID 20858702DOI 10.1530/eje-10-0818PUB-20858702

Full text at the publisher1 result

Publisher page See results (1)

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years up to 50 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Written and oral consent before enrollment * Legally competent subjects * Healthy (except uncomplicated hypertension and hypercholesterolemia) * Male sex * Age ≥ 18 years and ≤ 50 years * BMI 25-35 Exclusion Criteria: * Any condition which the investigator considers might affect the participant's ability to complete the study * Known of presumed acute of chronic illness

PepBank is a research reference. Talk to a doctor before you use any peptide.