Diabetes
Conditions
Keywords
GH and IGF-I, growth hormone deficiency and IGT or diabetes
Brief summary
The aim of this study is to measure effects of the combined treatment with GH and IGF-I on glucose sensitivity and body composition in patients with GHD and IGT or diabetes.
Detailed description
The study was a 6 months randomised placebo controlled trial of adults with GHD and type 2 diabetes. All receive GH (0.15 mg/day for 1 month, 0.3 mg/day for 5 months) and are randomised to IGF-I or placebo (15 µg/kg/day for 1 month and 30 µg/kg/day for 5 months). Glucose metabolism is evaluated with euglycemic hyperinsulinemic clamp and body composition by computed tomography (CT) and bio impedance;.
Interventions
DRUGNutropinAq (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)
DRUGNutropinAq and placebo
NutropinAq (0.15 mg/d for 1 month, 0.3 mg/d for 5 months) and placebo for 6 months.
Sponsors
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Verified profound GH deficiency. If the patient is already on GH replacement therapy this must have been commenced at least 6 months prior to study entry. 2. Impaired glucose tolerance test or diabetes (stable on oral antidiabetic medication for at least 3 months) 3. HbA1C\<7.5% 4. Age 18-70 years 5. Each patient must sign an informed consent document before inclusion in the study 6. Women of childbearing potential must provide a negative pregnancy test before study start, and they must agree to use an effective method of contraception such as double barrier contraception, an injectable or implanted hormonal contraceptive, combined oral contraceptive or an intra-uterine device (IUD). The patient must agree to continue to use the contraceptive for two weeks after the last injection of IMP. Women without childbearing potential are defined as being postmenopausal for at least 1 year, or permanently sterilised at least 3 months before study entry. \-
Exclusion criteria
1. Known or suspected allergy to GH or IGF-I preparation 2. Insulin treatment 3. Proliferative retinopathy 4. Previous malignancy or other serious diseases (ex severe cardiovascular diseases, severe infections). Patients with a history of cancer can be included if they have been treated with curative therapy and have been disease free for more than 5 years. Patients with cardiac failure are not included. 5. Increased liver enzymes (ASAT or ALAT\>2.5 normal range) 6. S-creatinine above 120 umol/L 7. Patients with active hyperthyroidism and untreated hypothyroidism 8. Pregnancy 9. Lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin sensitivity | start and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| body composition | start and 6 months |
Countries
Sweden
Outcome results
None listed