Metabolic Effects of Growth Hormone (GH) and Insulin-like Growth Factor-I (IGF-I)in Growth Hormone Deficient(GHD) and Diabetes and Impaired Glucose Tolerance(IGT)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Karolinska University Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Karolinska University Hospital
Information provided by:
Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01020955
First received: November 25, 2009
Last updated: July 1, 2011
Last verified: November 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes |
Drug: NutropinAq (GH) and Increlex (IGF-I) Drug: NutropinAq and placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
| Official Title: | Effects on Insulin Sensitivity and Body Composition of GH and IGF-I in Adult-GHD With Impaired Glucose Tolerance or Diabetes |
Resource links provided by NLM:
Drug Information available for:
Somatropin
Insulin-like growth factor I
Mecasermin
Mecasermin rinfabate
U.S. FDA Resources
Further study details as provided by Karolinska University Hospital:
Primary Outcome Measures:
- Insulin sensitivity [ Time Frame: start and 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- body composition [ Time Frame: start and 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 16 |
| Study Start Date: | October 2009 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: NutropinAq and Increlex |
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)
Other Names:
|
| Placebo Comparator: NutropinAq and placebo |
Drug: NutropinAq and placebo
NutropinAq (0.15 mg/d for 1 month, 0.3 mg/d for 5 months) and placebo (15 µg/kg/d for 1 month, 30 µg/kg/d for 5 months)
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
- Impaired glucose tolerance test or diabetes (stable on oral antidiabetic medication for at least 3 months)
- HbA1C<7.5%
- Age 18-70 years
- Each patient must sign an informed consent document before inclusion in the study
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:
- Known or suspected allergy to GH or IGF-I preparation
- Insulin treatment
- Proliferative retinopathy
- 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.
- Increased liver enzymes (ASAT or ALAT>2.5 normal range)
- S-creatinine above 120 umol/L
- Patients with active hyperthyroidism and untreated hypothyroidism
- Pregnancy
- Lactation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020955
Contacts
| Contact: Charlotte Hoeybye, MD | +46-851775379 | charlotte.hoybye@karolinska.se |
Locations
| Sweden | |
| Department of Endocrinology, karolinska University hospital | Recruiting |
| Solna, Sweden, 171 76 | |
| Contact: Charlotte Hoeybye, MD +46-851775379 charlotte.hoybye@karolinska.se | |
| Principal Investigator: Charlotte Hoeybye, MD | |
Sponsors and Collaborators
Karolinska University Hospital
Investigators
| Principal Investigator: | Charlotte Hoeybye, MD | Karolinska UH |
More Information
No publications provided
| Responsible Party: | Charlotte Hoeybye, Karolinska University Hospital |
| ClinicalTrials.gov Identifier: | NCT01020955 History of Changes |
| Other Study ID Numbers: | GH/IGF-I |
| Study First Received: | November 25, 2009 |
| Last Updated: | July 1, 2011 |
| Health Authority: | Sweden: Medical Products Agency |
Keywords provided by Karolinska University Hospital:
|
GH and IGF-I growth hormone deficiency and IGT or diabetes |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glucose Intolerance Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Hyperglycemia Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013