Growth Hormone Treatment in Men With High Risk of Developing Type 2 Diabetes Mellitus (GHDM)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Göteborg University
ClinicalTrials.gov Identifier:
NCT00781547
First received: October 28, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

The overall aim of this study is to investigate the effects of GH treatment in men with the Metabolic Syndrome and a high risk of developing type 2 DM.

Forty men with abdominal obesity and impaired glucose tolerance will be randomized to two parallel treatment groups with GH and placebo for 12 months.

The subjects will receive treatment with recombinant human GH (Genotropin®) or placebo administered by a daily s.c. injection before bedtime. The initial dose of GH will be 0.4 IU per day increased to 0.8 IU after 2 weeks and to 1.2 IU after 4 weeks of treatment. Thus, the target dose is 1.2 IU per day which resembles approximately 0.015 IU/kg/day. The GH dose will be reduced by half in the event of side-effects. Oral and written instructions in terms of administration and dosage will be given.

The treatment can be discontinued by the patient. The treatment should be discontinued if malignancy is discovered, DM developes, if the subject experience a cerebrovascular disease and in the event of any other side-effects that is considered as serious.

The treatment code for each subject included in the trial will be kept at the Sahlgrenska University Hospital Pharmacy. This code can be broken on the request of the investigator.

Compliance will be assessed by collecting empty vials from the study subjects. The treatment is discontinued at the end of the study.


Condition Intervention Phase
Abdominal Obesity
Metabolic Syndrome
Obesity
Drug: recombinant human growth hormone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • Glucose tolerance [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting plasma glucose, serum insulin, HbA1c [ Time Frame: Basline, 1,2,3,6,9 and 12 months ] [ Designated as safety issue: No ]
  • Sleep architecture [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Visceral adipose tissue [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Progress of atherosclerosis (IMT) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 1999
Study Completion Date: May 2005
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Recombinant human growth hormone
The subjects will receive treatment with recombinant human GH (Genotropin®) or placebo administered by a daily s.c. injection before bedtime. The initial dose of GH will be 0.4 IU per day increased to 0.8 IU after 2 weeks and to 1.2 IU after 4 weeks of treatment. Thus, the target dose is 1.2 IU per day which resembles approximately 0.015 IU/kg/day. The GH dose will be reduced by half in the event of side-effects
Drug: recombinant human growth hormone
The subjects will receive treatment with recombinant human GH (Genotropin®) or placebo administered by a daily s.c. injection before bedtime. The initial dose of GH will be 0.4 IU per day increased to 0.8 IU after 2 weeks and to 1.2 IU after 4 weeks of treatment. Thus, the target dose is 1.2 IU per day which resembles approximately 0.015 IU/kg/day. The GH dose will be reduced by half in the event of side-effects
Placebo Comparator: Placebo Drug: recombinant human growth hormone
The subjects will receive treatment with recombinant human GH (Genotropin®) or placebo administered by a daily s.c. injection before bedtime. The initial dose of GH will be 0.4 IU per day increased to 0.8 IU after 2 weeks and to 1.2 IU after 4 weeks of treatment. Thus, the target dose is 1.2 IU per day which resembles approximately 0.015 IU/kg/day. The GH dose will be reduced by half in the event of side-effects

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fasting plasma glucose level ≥ 6.1 and ≤ 7.8 mmol/L (IFG) and/or a plasma glucose 2 hours after a 75g oral glucose load between 6.9-11.0 mmol/L (IGT).
  • BMI > 25 kg/m2.
  • Waist/hip ratio > 0.95

Exclusion Criteria:

  • Proliferative diabetic retinopathy.
  • Macro-albuminuri and/or serum creatinine >150mmol/L
  • Known ischemic heart disease, previous stroke or claudicatio intermittence.
  • Known malignancy.
  • Other hormonal therapy.
  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: NCT00781547

Locations
Sweden
Centrum for Endocrinology and Metabolism, Sahlgenska University Hospital
Gothenburg, Sweden, 413 45
Sponsors and Collaborators
Göteborg University
Pfizer
  More Information

No publications provided

Responsible Party: Gudmundur Johannsson, Department of Endocrinology, Sahlgrenska University Hospital, 413 45 Gothenburg, Sweden
ClinicalTrials.gov Identifier: NCT00781547     History of Changes
Other Study ID Numbers: GHNIDDM
Study First Received: October 28, 2008
Last Updated: October 28, 2008
Health Authority: Sweden: Medical Products Agency

Keywords provided by Göteborg University:
growth hormone
obesity
abdominal obesity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Obesity, Abdominal
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014