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

  • Sweden
      • Solna, Sweden, 171 76
        • Department of Endocrinology, Karolinska University Hospital

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:

  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

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
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:
  • Placebo
  • NutropinAq (GH)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Insulin sensitivity
Time Frame: start and 6 months
start and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
body composition
Time Frame: start and 6 months
start and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

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

Keywords

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.

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