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

Obesity Clinical Trial

— GHDM  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00781547
• Other study ID #: GHNIDDM
• Status: Completed
• Phase: Phase 3
• First received: October 28, 2008
• Last updated: October 28, 2008
• Start date: January 1999
• Est. completion date: May 2005

Study information

• Verified date: October 2008
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2005
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Obesity
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Obesity, Abdominal

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Sweden	Centrum for Endocrinology and Metabolism, Sahlgenska University Hospital	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Pfizer

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose tolerance		Baseline, 3, 6 and 12 months	No
Secondary	Fasting plasma glucose, serum insulin, HbA1c		Basline, 1,2,3,6,9 and 12 months	No
Secondary	Sleep architecture		Baseline and 12 months	No
Secondary	Visceral adipose tissue		Baseline and 12 months	No
Secondary	Progress of atherosclerosis (IMT)		Baseline and 12 months	No