Metabolic Effects of GH and IGF-I in Growth Hormone Deficient(GHD) and Diabetes and Impaired Glucose Tolerance(IGT)
April 6, 2015 updated by: Charlotte Hoeybye, Karolinska University Hospital
Effects on Insulin Sensitivity and Body Composition of GH and IGF-I in Adult-GHD With Impaired Glucose Tolerance or Diabetes
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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;.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Solna, Sweden, 171 76
- Department of Endocrinology, Karolinska University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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ACTIVE_COMPARATOR: 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).
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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
NutropinAq (0.15 mg/day for 1 month, 0.3 mg/day for 5 months) and placebo for 6 months.
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NutropinAq (0.15 mg/d for 1 month, 0.3 mg/d for 5 months) and placebo for 6 months.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Insulin sensitivity
Time Frame: start and 6 months
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start and 6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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body composition
Time Frame: start and 6 months
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start and 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Charlotte Hoeybye, MD, Karolinska UH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (ACTUAL)
November 1, 2011
Study Completion (ACTUAL)
November 1, 2011
Study Registration Dates
First Submitted
November 25, 2009
First Submitted That Met QC Criteria
November 25, 2009
First Posted (ESTIMATE)
November 26, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
April 7, 2015
Last Update Submitted That Met QC Criteria
April 6, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GH/IGF-I
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.