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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Charlotte Hoeybye, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01020955
First received: November 25, 2009
Last updated: April 6, 2015
Last verified: April 2015
  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:


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 ]

Enrollment: 14
Study Start Date: October 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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:
  • NutropinAq (GH)
  • Increlex (IGF-I)
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.
Drug: NutropinAq and placebo
NutropinAq (0.15 mg/d for 1 month, 0.3 mg/d for 5 months) and placebo for 6 months.
Other Names:
  • NutropinAq (GH)
  • Placebo

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;.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01020955

Locations
Sweden
Department of Endocrinology, karolinska University hospital
Solna, Sweden, 171 76
Sponsors and Collaborators
Karolinska University Hospital
Investigators
Principal Investigator: Charlotte Hoeybye, MD Karolinska UH
  More Information

No publications provided

Responsible Party: Charlotte Hoeybye, MD, PhD, 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: April 6, 2015
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:
Glucose Intolerance
Glucose Metabolism Disorders
Hyperglycemia
Metabolic Diseases

ClinicalTrials.gov processed this record on August 02, 2015