Status:
WITHDRAWN
Low Dose Growth Hormone Treatment in Subjects With Metabolic Syndrome.
Lead Sponsor:
Oregon Health and Science University
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
Study hypothesis: Low dose growth hormone (GH), through its generation of free 'bioavailable' insulin-like growth factor (IGF)-I, can improve insulin sensitivity and the metabolic profile of subjects...
Detailed Description
The study will be a double-blinded randomized placebo-controlled cross-over study. Thirty subjects will be screened for eligibility initially, and the first 12 eligible subjects will be enrolled. Six ...
Eligibility Criteria
Inclusion
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- Age 21 to 65 years
- Body mass index between 25 to 40 kg/m2
- Diagnosis of MBS based on the consensus statement by the International Diabetes Federation i.e., central obesity defined by waist circumference in men of ≥ 94 cm and in women of ≥ 80 cm plus two other components from the following: 1) dyslipidemia (triglyceride levels ≥ 150 mg/dl or on therapy and/or HDL in men of \< 40 mg/dl and in women of \< 50 mg/dl or on therapy); 2) hypertension (blood pressure ≥ 130/85 mmHg or on therapy and 3) hyperglycemia (fasting plasma glucose ≥ 100 mg/dl or on therapy)
- Stable weight and diet for at least 6 months prior to study entry
- Normal thyroid function
- Normal renal and hepatic function
- Able to self administer GH/Placebo injections
Exclusion
- Inability to comply with study requirements
- Body mass index \< 30 kg/m2 and \> 40 kg/m2 (patients with body mass index \> 40 kg/m2 are excluded because they will not fit into the MRS scanner)
- Untreated hypothyroidism or hyperthyroidism
- Anemia from any cause
- Known diabetes mellitus
- Patients with an increased risk of venous thrombosis or previous history of recurrent venous thrombosis
- Patient on any insulin-sensitizers (e.g., Metformin, Rosiglitazone, Pioglitazone) within 30 days of screening assessment
- Patient on any anti-androgens (e.g., Spironolactone, Cyproterone acetate, Flutamide, Finasteride) within 30 days of screening assessment
- Patient with other concurrent illnesses
- Pregnant (positive pregnancy test) prior enrollment in the study or planning to conceive whilst participating in the study
- Emotional/social instability likely to prejudice study completion
- Previous history of known malignancy
- Recurrent or severe unexplained hypoglycemia
- Known or suspected drug/alcohol abuse
- Patient with any metals in the body
- Any other condition/s that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00720616
Start Date
October 1 2010
End Date
December 1 2012
Last Update
February 20 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Oregon Health and Science University
Portland, Oregon, United States, 97239