Growth Hormone Treatment in Men With High Risk of Developing Type 2 Diabetes Mellitus - Full Text View

Sponsors and Collaborators:	Göteborg University Gothenburg University Pfizer
Information provided by:	Göteborg University
ClinicalTrials.gov Identifier:	NCT00781547

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 III

MedlinePlus related topics: Diabetes Obesity

Drug Information available for: Somatotropin Somatropin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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
Recombinant human growth hormone: Experimental 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: Placebo Comparator	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

Arms

Assigned Interventions

Recombinant human growth hormone: Experimental

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: Placebo Comparator

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

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

Gothenburg University

Pfizer

More Information

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

Keywords provided by Göteborg University:

growth hormone
obesity
abdominal obesity

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Overweight
Body Weight
Signs and Symptoms

Diabetes Mellitus, Type 2
Nutrition Disorders
Overnutrition
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009