Abdominal Obesity, Metabolic Syndrome, Obesity
Conditions
Keywords
growth hormone, obesity, abdominal obesity
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.
Interventions
DRUGrecombinant 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
Sponsors
Pfizer
Göteborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
40 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glucose tolerance | Baseline, 3, 6 and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Progress of atherosclerosis (IMT) | Baseline and 12 months |
| 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 |
Countries
Sweden
Outcome results
None listed