Overview

Metabolic Effects of GH and IGF-I in Growth Hormone Deficient(GHD) and Diabetes and Impaired Glucose Tolerance(IGT)

Status:
Completed

Trial end date:
2011-11-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Karolinska University Hospital

Treatments:

Mecasermin

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