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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01020955
Recruitment Status : Completed
First Posted : November 26, 2009
Last Update Posted : April 7, 2015
Information provided by (Responsible Party):
Charlotte Hoeybye, Karolinska University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Drug: NutropinAq (GH) and Increlex (IGF-I) Drug: NutropinAq and placebo Phase 3

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  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: start and 6 months ]

Secondary Outcome Measures :
  1. body composition [ Time Frame: start and 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01020955

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

Responsible Party: Charlotte Hoeybye, MD, PhD, Karolinska University Hospital Identifier: NCT01020955     History of Changes
Other Study ID Numbers: GH/IGF-I
First Posted: November 26, 2009    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015

Keywords provided by Charlotte Hoeybye, 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
Growth Substances
Physiological Effects of Drugs