| Trial ID: | L6783 |
| Source ID: | NCT00781547
|
| Associated Drug: |
Recombinant Human Growth Hormone
|
| Title: |
Growth Hormone Treatment in Men With High Risk of Developing Type 2 Diabetes Mellitus
|
| Acronym: |
GHDM
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Abdominal Obesity|Metabolic Syndrome|Obesity
|
| Interventions: |
DRUG: recombinant human growth hormone
|
| Outcome Measures: |
Primary: Glucose tolerance, Baseline, 3, 6 and 12 months | Secondary: 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
|
| Sponsor/Collaborators: |
Sponsor: Göteborg University | Collaborators: Pfizer
|
| Gender: |
MALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
1999-01
|
| Completion Date: |
2005-05
|
| Results First Posted: |
|
| Last Update Posted: |
2008-10-29
|
| Locations: |
Centrum for Endocrinology and Metabolism, Sahlgenska University Hospital, Gothenburg, 413 45, Sweden
|
| URL: |
https://clinicaltrials.gov/show/NCT00781547
|