Low Dose Growth Hormone Treatment in Subjects With Metabolic Syndrome.

NCT00720616 | Withdrawn

• 1 other identifier: IRB4481
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Study hypothesis: Low dose growth hormone (GH), through its generation of free 'bioavailable' insulin-like growth factor (IGF)-I, can improve insulin sensitivity and the metabolic profile of subjects with metabolic syndrome. Study aims: The purpose of this study is to determine the mechanism of how low dose GH treatment affects the body's sensitivity to insulin actions and whether this low GH dose can affect the body's handling of steroid hormone levels (cortisol clearance) and fat deposition in subjects with metabolic syndrome. Study design: Subjects that satisfy the criteria of metabolic syndrome (central obesity, treated or untreated high blood pressure, high cholesterol and impaired fasting glucose levels) will be invited to participate in this study. The subjects will be assessed at the initial visit to ascertain their suitability before further participation in the study. If eligible, an equal number of men and women will be randomized (like a flip of a coin) to receive either daily low dose GH or placebo injections first for 12 weeks, before exchanging over for another 12 weeks of treatment after a 4-week washout period. Before, during and after treatment, the subjects will be assessed at frequently with blood tests, scans and fat biopsies. During the study, the subjects will be studied 4 times at the Oregon Clinical and Translational Research Institute (OCTRI). At the first, second and final visit, testing will include scans to measure the amount of whole body fat and fat in the stomach area, muscle, and liver; blood tests to measure levels of cortisol, and fat tissue (taken from a biopsy) analysis to measure the density of insulin-like growth factor-I (a hormone stimulated by growth hormone in the body) in fat; whereas blood tests to examine how well insulin works in the body (insulin sensitivity) will be collected at all visits of the study.

Conditions

Metabolic Syndrome

Keywords

Growth hormone; Metabolic syndrome; Insulin sensitivity

Outcome Measures

Primary Outcomes (1)

• Changes in insulin sensitivity, and adipocyte IGF-I and insulin receptor signaling.

  24 months

Secondary Outcomes (1)

• Changes in body composition, cortisol production rates, and muscle and liver intramyocellular content.

  24 months

Study Arms (1)

1

EXPERIMENTAL

Growth hormone or Placebo 0.1 mg/day self-administrated once a day.

Drug: Norditropin

Interventions

Norditropin DRUG

Norditropin 0.1 mg/day self-administered once a day subcutaneously

Also known as: Growth hormone, metabolic syndrome, insulin sensitivity

1

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study.
• Age 21 to 65 years
• Body mass index between 25 to 40 kg/m2
• Diagnosis of MBS based on the consensus statement by the International Diabetes Federation i.e., central obesity defined by waist circumference in men of ≥ 94 cm and in women of ≥ 80 cm plus two other components from the following: 1) dyslipidemia (triglyceride levels ≥ 150 mg/dl or on therapy and/or HDL in men of \< 40 mg/dl and in women of \< 50 mg/dl or on therapy); 2) hypertension (blood pressure ≥ 130/85 mmHg or on therapy and 3) hyperglycemia (fasting plasma glucose ≥ 100 mg/dl or on therapy)
• Stable weight and diet for at least 6 months prior to study entry
• Normal thyroid function
• Normal renal and hepatic function
• Able to self administer GH/Placebo injections

You may not qualify if:

• Inability to comply with study requirements
• Body mass index \< 30 kg/m2 and \> 40 kg/m2 (patients with body mass index \> 40 kg/m2 are excluded because they will not fit into the MRS scanner)
• Untreated hypothyroidism or hyperthyroidism
• Anemia from any cause
• Known diabetes mellitus
• Patients with an increased risk of venous thrombosis or previous history of recurrent venous thrombosis
• Patient on any insulin-sensitizers (e.g., Metformin, Rosiglitazone, Pioglitazone) within 30 days of screening assessment
• Patient on any anti-androgens (e.g., Spironolactone, Cyproterone acetate, Flutamide, Finasteride) within 30 days of screening assessment
• Patient with other concurrent illnesses
• Pregnant (positive pregnancy test) prior enrollment in the study or planning to conceive whilst participating in the study
• Emotional/social instability likely to prejudice study completion
• Previous history of known malignancy
• Recurrent or severe unexplained hypoglycemia
• Known or suspected drug/alcohol abuse
• Patient with any metals in the body

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Yuen K, Wareham N, Frystyk J, Hennings S, Mitchell J, Fryklund L, Dunger D. Short-term low-dose growth hormone administration in subjects with impaired glucose tolerance and the metabolic syndrome: effects on beta-cell function and post-load glucose tolerance. Eur J Endocrinol. 2004 Jul;151(1):39-45. doi: 10.1530/eje.0.1510039.

  PMID: 15248820 BACKGROUND

Related Links

• American Endocrine Society

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance

Interventions

Human Growth Hormone; Growth Hormone; Insulin

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Proinsulin; Insulins; Pancreatic Hormones

Study Officials

• Kevin C. Yuen, MRCP(UK), MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Endocrinology

Study Record Dates

• First Submitted: July 21, 2008
• First Posted: July 23, 2008
• Study Start: October 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 20, 2013

Record last verified: 2013-02

Locations

US (1)