Status:
COMPLETED
Growth Hormone Treatment in Men With High Risk of Developing Type 2 Diabetes Mellitus
Lead Sponsor:
Göteborg University
Collaborating Sponsors:
Pfizer
Conditions:
Abdominal Obesity
Metabolic Syndrome
Eligibility:
MALE
40-65 years
Phase:
PHASE3
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 g...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00781547
Start Date
January 1 1999
End Date
May 1 2005
Last Update
October 29 2008
Active Locations (1)
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1
Centrum for Endocrinology and Metabolism, Sahlgenska University Hospital
Gothenburg, Sweden, 413 45