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

NCT ID: NCT01020955

Last Updated: 2015-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-11-30

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;.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: QUADRUPLE

Study Groups

NutropinAq and Increlex

NutropinAq (0.15 mg/day for 1 month, 0.3 mg/day for 5 months) and Increlex (15 µg/kg/day for 1 month and 30 µg/kg/day for 5 months).

Group Type: ACTIVE_COMPARATOR

NutropinAq (GH) and Increlex (IGF-I)

Intervention Type: DRUG

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/day for 1 month, 0.3 mg/day for 5 months) and placebo for 6 months.

Group Type: PLACEBO_COMPARATOR

NutropinAq and placebo

Intervention Type: DRUG

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

Interventions

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)

Intervention Type: DRUG

NutropinAq and placebo

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

Intervention Type: DRUG

Other Intervention Names

NutropinAq (GH); Increlex (IGF-I); NutropinAq (GH); Placebo

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.

-

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Charlotte Hoeybye

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charlotte Hoeybye, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska UH

Locations

Department of Endocrinology, karolinska University hospital

Solna, Sweden, Sweden

Countries

Sweden

Other Identifiers

GH/IGF-I

Identifier Type: -

Identifier Source: org_study_id