Metabolic Effects of GH and IGF-I in Growth Hormone Deficient(GHD) and Diabetes and Impaired Glucose Tolerance(IGT)
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|ClinicalTrials.gov Identifier: NCT01020955|
Recruitment Status : Completed
First Posted : November 26, 2009
Last Update Posted : April 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Drug: NutropinAq (GH) and Increlex (IGF-I) Drug: NutropinAq and placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects on Insulin Sensitivity and Body Composition of GH and IGF-I in Adult-GHD With Impaired Glucose Tolerance or Diabetes|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
Active Comparator: NutropinAq and Increlex
NutropinAq (0.15 mg/day for 1 month, 0.3 mg/day for 5 months) and Increlex (15 µg/kg/day for 1 month and 30 µg/kg/day for 5 months).
Drug: NutropinAq (GH) and Increlex (IGF-I)
NutropinAq (GH)(0.15 mg/d for 1 month, 0.3 mg/d for 5 months) and Increlex (IGF-I) (15 µg/kg/d for 1 month, 30 µg/kg/d for 5 months)
Placebo Comparator: NutropinAq and placebo
NutropinAq (0.15 mg/day for 1 month, 0.3 mg/day for 5 months) and placebo for 6 months.
Drug: NutropinAq and placebo
NutropinAq (0.15 mg/d for 1 month, 0.3 mg/d for 5 months) and placebo for 6 months.
- Insulin sensitivity [ Time Frame: start and 6 months ]
- body composition [ Time Frame: start and 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01020955
|Department of Endocrinology, karolinska University hospital|
|Solna, Sweden, 171 76|
|Principal Investigator:||Charlotte Hoeybye, MD||Karolinska UH|