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

Diabetes Clinical Trial

Official title:

Effects on Insulin Sensitivity and Body Composition of GH and IGF-I in Adult-GHD With Impaired Glucose Tolerance or Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01020955
• Other study ID #: GH/IGF-I
• Status: Completed
• Phase: Phase 3
• First received: November 25, 2009
• Last updated: April 6, 2015
• Start date: October 2009
• Est. completion date: November 2011

Study information

• Verified date: April 2015
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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;.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Diabetes
• Glucose Intolerance

Intervention

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)
• NutropinAq and placebo
NutropinAq (0.15 mg/d for 1 month, 0.3 mg/d for 5 months) and placebo for 6 months.

Locations

Country	Name	City	State
Sweden	Department of Endocrinology, karolinska University hospital	Solna

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity		start and 6 months	No
Secondary	body composition		start and 6 months	No