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

Göteborg University

Status and phase: Completed; Phase 3

Conditions: Abdominal Obesity; Obesity; Metabolic Syndrome

Treatments: Drug: recombinant human growth hormone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00781547

GHNIDDM

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Male

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Recombinant human growth hormone

Experimental group

Description:

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

Treatment:

Drug: recombinant human growth hormone

Placebo

Placebo Comparator group

Treatment:

Drug: recombinant human growth hormone