Growth Hormone Treatment in Men With High Risk of Developing Type 2 Diabetes Mellitus

Phase 3

Completed

• Conditions: Abdominal Obesity; Metabolic Syndrome; Obesity
• Interventions: Drug: recombinant human growth hormone

• Registration Number: NCT00781547
• Lead Sponsor: Göteborg University

Brief Summary

The overall aim of this study is to investigate the effects of GH treatment in men with the Metabolic Syndrome and a high risk of developing type 2 DM.

Forty men with abdominal obesity and impaired glucose tolerance will be randomized to two parallel treatment groups with GH and placebo for 12 months.

The subjects will receive treatment with recombinant human GH (Genotropin®) or placebo administered by a daily s.c. injection before bedtime. The initial dose of GH will be 0.4 IU per day increased to 0.8 IU after 2 weeks and to 1.2 IU after 4 weeks of treatment. Thus, the target dose is 1.2 IU per day which resembles approximately 0.015 IU/kg/day. The GH dose will be reduced by half in the event of side-effects. Oral and written instructions in terms of administration and dosage will be given.

The treatment can be discontinued by the patient. The treatment should be discontinued if malignancy is discovered, DM developes, if the subject experience a cerebrovascular disease and in the event of any other side-effects that is considered as serious.

The treatment code for each subject included in the trial will be kept at the Sahlgrenska University Hospital Pharmacy. This code can be broken on the request of the investigator.

Compliance will be assessed by collecting empty vials from the study subjects. The treatment is discontinued at the end of the study.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-01
• Primary Completion: 2003-09
• Study Completion: 2005-05
• Status Verified: 2008-10
• Study First Submitted: 2008-10-28
• Study First Submitted QC: 2008-10-28
• Last Update Submitted: 2008-10-28
• Study First Posted: 2008-10-29
• Last Update Posted: 2008-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Fasting plasma glucose level ≥ 6.1 and ≤ 7.8 mmol/L (IFG) and/or a plasma glucose 2 hours after a 75g oral glucose load between 6.9-11.0 mmol/L (IGT).
• BMI > 25 kg/m2.
• Waist/hip ratio > 0.95

Exclusion Criteria

• Proliferative diabetic retinopathy.
• Macro-albuminuri and/or serum creatinine >150mmol/L
• Known ischemic heart disease, previous stroke or claudicatio intermittence.
• Known malignancy.
• Other hormonal therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Recombinant human growth hormone	recombinant human growth hormone	The subjects will receive treatment with recombinant human GH (Genotropin®) or placebo administered by a daily s.c. injection before bedtime. The initial dose of GH will be 0.4 IU per day increased to 0.8 IU after 2 weeks and to 1.2 IU after 4 weeks of treatment. Thus, the target dose is 1.2 IU per day which resembles approximately 0.015 IU/kg/day. The GH dose will be reduced by half in the event of side-effects
Placebo	recombinant human growth hormone	-

Primary Outcome Measures

Name	Time	Method
Glucose tolerance	Baseline, 3, 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
Fasting plasma glucose, serum insulin, HbA1c	Basline, 1,2,3,6,9 and 12 months
Sleep architecture	Baseline and 12 months
Visceral adipose tissue	Baseline and 12 months
Progress of atherosclerosis (IMT)	Baseline and 12 months

Trial Locations

Locations (1)

Centrum for Endocrinology and Metabolism, Sahlgenska University Hospital; 🇸🇪 Gothenburg, Sweden