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OpenTrials
Completed

NCT Number: NCT02782208

Lipolytic Effects of GH in Hypopituitary Patients in Vivo

Growth hormone (GH) is essential for longitudinal bone growth and somatic development. These protein anabolic effects require sufficient nutritional supply. During fasting and caloric restriction GH predominantly promotes fat metabolism.

GH counteracts the effect of insulin in many tissues, of which insulin-stimulated glucose uptake in skeletal muscle has been most extensively studied. Substrate competition between elevated free fatty acids and glucose is suggested as a mechanism, and this hypothesis can be tested mechanistically by means of acipimox, which is a nicotinic acid that suppresses the fat metabolizing effects of GH.

The hypothesis is, that the suppressive effect of GH on insulin-stimulated glucose uptake in skeletal muscle is obviated by acipimox-induced inhibition of fat metabolism.

In order to investigate this, eight adult hypopituitary patients with documented GH-deficiency will be studied in the presence and absence of GH and acipimox, respectively, and biopsies from skeletal muscle and subcutaneous adipose tissue will be analyzed.

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Aarhus

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • hypopituitary patients with documented GH-deficiency

Exclusion criteria

  • other significant disease

Treatment and study plan

Acipimox

Drug

Acipimox is administered 4 times previous to and during the investigation day. Acipimox is used to suppress the lipolytic effect of GH.

Other names: Olbetam

Placebo

Drug

Placebo is administered 4 times previous to and during the investigation day.

GH substitution

Drug

GH substitution as usually

GH pause

Other

GH substitution pause two days prior to the experimental day

Primary outcomes

  1. Lipolytic activity measured as area under the curve (AUC) for FFA (free fatty acid) before and during clamp-conditions.

    Time frame: 1 year

Secondary outcomes

  1. GH signaling proteins and gene targets in adipose and skeletal muscle tissues measured by western blotting and qPCR

    Time frame: 1,5 years

  2. Insulin sensitivity as measured by M value and GIR (glucose infusion rate)

    Time frame: 6 months

  3. Substrate metabolism as measured by indirect calorimetry, tritiated glucose and circulating hormones and metabolites

    Time frame: 1 year

  4. PDH (pyruvate dehydrogenase) activity in skeletal muscle measured by an PDH activity assay

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Lipolytic Effects of GH in Hypopituitary Patients in Vivo: Molecular Mechanisms and Temporal Patterns.

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 25, 2016
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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