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