Growth Hormone Treatment in Men With High Risk of Developing Type 2 Diabetes Mellitus (GHDM)
Primary Purpose
Abdominal Obesity, Metabolic Syndrome, Obesity
Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
recombinant human growth hormone
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Obesity focused on measuring growth hormone, obesity, abdominal obesity
Eligibility Criteria
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.
Sites / Locations
- Centrum for Endocrinology and Metabolism, Sahlgenska University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Recombinant human growth hormone
Placebo
Arm 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
Outcomes
Primary Outcome Measures
Glucose tolerance
Secondary Outcome Measures
Fasting plasma glucose, serum insulin, HbA1c
Sleep architecture
Visceral adipose tissue
Progress of atherosclerosis (IMT)
Full Information
NCT ID
NCT00781547
First Posted
October 28, 2008
Last Updated
October 28, 2008
Sponsor
Göteborg University
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00781547
Brief Title
Growth Hormone Treatment in Men With High Risk of Developing Type 2 Diabetes Mellitus
Acronym
GHDM
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
September 2003 (Actual)
Study Completion Date
May 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Göteborg University
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Obesity, Metabolic Syndrome, Obesity
Keywords
growth hormone, obesity, abdominal obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Recombinant human growth hormone
Arm Type
Experimental
Arm 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
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
recombinant human growth hormone
Intervention 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
Primary Outcome Measure Information:
Title
Glucose tolerance
Time Frame
Baseline, 3, 6 and 12 months
Secondary Outcome Measure Information:
Title
Fasting plasma glucose, serum insulin, HbA1c
Time Frame
Basline, 1,2,3,6,9 and 12 months
Title
Sleep architecture
Time Frame
Baseline and 12 months
Title
Visceral adipose tissue
Time Frame
Baseline and 12 months
Title
Progress of atherosclerosis (IMT)
Time Frame
Baseline and 12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Centrum for Endocrinology and Metabolism, Sahlgenska University Hospital
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden
12. IPD Sharing Statement
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Growth Hormone Treatment in Men With High Risk of Developing Type 2 Diabetes Mellitus
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