Lipolytic Effects of GH in Hypopituitary Patients in Vivo

University of Aarhus

Status

Completed

Conditions

Metabolic Diseases

Pituitary Diseases

Glucose Metabolism Disorders

Insulin Resistance

Brain Diseases

Endocrine System Diseases

Hypopituitarism

Treatments

Drug: Acipimox

Other: GH pause

Drug: GH substitution

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02782208

GHD01

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

Male

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

hypopituitary patients with documented GH-deficiency

Exclusion criteria

other significant disease

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Triple Blind

9 participants in 4 patient groups, including a placebo group

Acipimox/GH substitution

Active Comparator group

Description:

Drug: Acipimox Tablet Acipimox 250 mg administered 4 times previous to and during the investigation day Other Name: Tablet Olbetam 250 mg Continue GH substitution as usually.

Treatment:

Drug: Acipimox

Drug: GH substitution

Acipimox/GH pause

Active Comparator group

Description:

Drug: Acipimox Tablet Acipimox 250 mg administered 4 times previous to and during the investigation day Other Name: Tablet Olbetam 250 mg Pause GH substitution to days prior to the study day.

Treatment:

Other: GH pause

Drug: Acipimox

Placebo/GH substitution

Placebo Comparator group

Description:

Drug: Placebo tablets Continue GH substitution as usually.

Treatment:

Drug: Placebo

Drug: GH substitution

Placebo/GH pause

Placebo Comparator group