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

Study Overview
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Brief Summary
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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.

Conditions
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Abdominal Obesity, Metabolic Syndrome, Obesity

Intervention / Treatment
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* Drug: recombinant human growth hormone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recombinant human growth hormone<br>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 | Drug: recombinant human growth hormone<br>* 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<br>|
| Placebo Comparator: Placebo<br> | Drug: recombinant human growth hormone<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose tolerance |  | Baseline, 3, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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growth hormone, obesity, abdominal obesity