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

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ClinicalTrials.gov Identifier: NCT00781547
Recruitment Status : Completed
First Posted : October 29, 2008
Last Update Posted : October 29, 2008
Sponsor:
Collaborator:
Pfizer
Information provided by:
Göteborg University

Brief Summary:

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 or disease Intervention/treatment Phase
Abdominal Obesity Metabolic Syndrome Obesity Drug: recombinant human growth hormone Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 1999
Actual Primary Completion Date : September 2003
Actual Study Completion Date : May 2005


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Glucose tolerance [ Time Frame: Baseline, 3, 6 and 12 months ]

Secondary Outcome Measures :
  1. Fasting plasma glucose, serum insulin, HbA1c [ Time Frame: Basline, 1,2,3,6,9 and 12 months ]
  2. Sleep architecture [ Time Frame: Baseline and 12 months ]
  3. Visceral adipose tissue [ Time Frame: Baseline and 12 months ]
  4. Progress of atherosclerosis (IMT) [ Time Frame: Baseline and 12 months ]


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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes 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.

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 ClinicalTrials.gov identifier (NCT number): NCT00781547


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

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
First Posted: October 29, 2008    Key Record Dates
Last Update Posted: October 29, 2008
Last Verified: October 2008

Keywords provided by Göteborg University:
growth hormone
obesity
abdominal obesity

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