Clinical trial NCT01020955: Metabolic Effects of GH and IGF-I in Growth Hormone Deficient(GHD) and Diabetes and Impaired Glucose Tolerance(IGT)
Official title: Effects on Insulin Sensitivity and Body Composition of GH and IGF-I in Adult-GHD With Impaired Glucose Tolerance or Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Keywords: GH and IGF-I
growth hormone deficiency and IGT or diabetes
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2009-11-26
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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;.

Eligibility criteria: 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.

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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

Primary outcomes:
measure: Insulin sensitivity
timeFrame: start and 6 months
Secondary outcomes:
measure: body composition
timeFrame: start and 6 months
Other outcomes:
Locations:
city: Solna
country: Sweden
facility: Department of Endocrinology, karolinska University hospital
Study officials:
affiliation: Karolinska UH
name: Charlotte Hoeybye, MD
role: PRINCIPAL_INVESTIGATOR
References: