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

Last updated: April 6, 2015
Sponsor: Karolinska University Hospital
Overall Status: Completed

Phase

3

Condition

Diabetic Macular Edema

Diabetic Kidney Disease

Diabetic Foot Ulcers

Treatment

N/A

Clinical Study ID

NCT01020955
GH/IGF-I
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Verified profound GH deficiency. If the patient is already on GH replacement therapythis must have been commenced at least 6 months prior to study entry.

  2. Impaired glucose tolerance test or diabetes (stable on oral antidiabetic medicationfor 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 studystart, and they must agree to use an effective method of contraception such as doublebarrier contraception, an injectable or implanted hormonal contraceptive, combinedoral contraceptive or an intra-uterine device (IUD). The patient must agree tocontinue to use the contraceptive for two weeks after the last injection of IMP. Womenwithout childbearing potential are defined as being postmenopausal for at least 1year, or permanently sterilised at least 3 months before study entry.

Exclusion

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 havebeen 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

Study Design

Total Participants: 14
Study Start date:
October 01, 2009
Estimated Completion Date:
November 30, 2011

Study 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;.

Connect with a study center

  • Department of Endocrinology, karolinska University hospital

    Solna, 171 76
    Sweden

    Site Not Available

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