Effects on insulin sensitivity and body composition of combination therapy with growth hormone (GH) and insulin-like growth factor-I (IGF-I) in growth hormone deficient adults with impaired glucose tolerance or diabetes - GH-IGF-I
- Conditions
- To evaluate the effect on glucose sensitivity and body composition of combination therapy with GH and IGF-I in growth hormone deficient adults with impaired glucose tolerance or diabetes. The hypothesis of the study is that the combination therapy improves glucose metabolism and increases GH’s effect on body composition.
- Registration Number
- EUCTR2009-011534-10-SE
- Lead Sponsor
- Karolinska University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Subjects who meet all of the following criteria are eligible for this trial:
Verified profound GH deficiency
Impaired glucose tolerance test or diabetes (stable on antidiabetic medication)
Age 18-70 years
Each patient must sign an informed consent document before inclusion in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Subjects meeting one or more of the following criteria cannot be selected:
Known or suspected allergy to GH or IGF-I preparation
GH treatment within the last year
Insulin treatment
Diabetes with HbA1C>9%
Malignancy or other serious diseases (ex severe cardiovascular diseases, severe infections)
Increased liver enzymes (ASAT or ALAT>2.5 normal range)
Pregnancy
Lactation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effect on glucose sensitivity and body composition of combination therapy with GH and IGF-I in growth hormone deficient adults with impaired glucose tolerance or diabetes. The hypothesis of the study is that the combination therapy improves glucose metabolism and increases GH’s effect on body composition.;Secondary Objective: Changes in BMI, waist circumference, serum lipids (triglycerides, total cholesterol, HDL- and LDL cholesterol), IGF-I, IGFBP-1 and adiponectin. ;Primary end point(s): Insulin sensitivity evaluated with hyperinsulinemic euglycemic clamp <br>HbA1c <br>
- Secondary Outcome Measures
Name Time Method