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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-011534-10-SE
Enrollment
Unknown
Registered
2009-04-24
Start date
2009-06-23
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Trade Name: NutropinAQ and Increlex Product Name: NutropiAq and Increlex Pharmaceutical Form: Suspension for injection Pharmaceutical form of the placebo: Suspension for injection Route of administrat

Sponsors

Karolinska University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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 HbA1c—

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026