Growth Hormone and Glucose Metabolism

NCT00929799 | Completed Phase 4

• 2 other identifiers: NRA 6280012EK218-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate changes in insulin sensitivity and ß-cell function after 24 and 48 weeks of low-dose growth hormone (GH) therapy in adult patients with severe GH deficiency using highly standardized techniques. Insulin sensitivity was estimated using euglycemic, hyperinsulinemic clamps, while insulin secretion and hepatic insulin clearance were determined by changes in insulin and C-peptide levels during hyperglycemic hyperinsulinemic clamps with consecutive intravenous (i.v.) L-arginine stimulation tests. Moreover, the researchers investigated changes in body composition, lipolysis and cardiovascular risk markers. Furthermore, in order to verify the mechanisms involved in the pathogenesis of GH-induced insulin resistance and the GH-induced improvement in insulin resistance under long term treatment, the researchers intend to establish changes in intramyocellular lipid (IMCL) in patients with GH deficiency by magnetic resonance (MR)-spectroscopy before and during GH-treatment and to correlate IMCL with insulin resistance, insulin secretion and insulin clearance. Finally, the researchers aim to justify the effect of GH on adiponectin secretion as well as on the 11-ß hydroxylase activity.

Conditions

Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

• Change from baseline in insulin sensitivity after 24 and 48 weeks of treatment with low GH dose in severely GH deficient patients.

  At 24 and 48 weeks of treatment

Secondary Outcomes (1)

• Changes from baseline in insulin secretion and insulin clearance, as well as changes in body composition, lipolysis, cardiovascular risk markers, Adiponectin, IMCL and 11ßHSD activity.

  At 24 and 48 weeks of treatment

Study Arms (1)

Growth Hormone

EXPERIMENTAL

Therapy with recombinant human GH (Genotropin® 1 mg = 3 IU, Pfizer Inc., NY, USA) daily by subcutaneous injection using a Genotropin pen at maximal GH dose of 0.003 mg/kg/day in patients with severe GHD

Drug: recombinant human Growth Hormone (Genotropin® )

Interventions

recombinant human Growth Hormone (Genotropin® ) DRUG

Once daily by subcutaneous injection using a Genotropin pen in the abdomen at 22:00 h. Maximal GH dose of 0.003 mg/kg/day.

Growth Hormone

Eligibility Criteria

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

You may qualify if:

• Patients \>18 years old.
• Severe GH deficiency as diagnosed by an inadequate GH stimulation in three different tests:
• peak response \< 3 µg/l during an insulin tolerance test;
• \< 3 µg/l during glucagon test;
• \< 9 µg/l during GHRH-arginine stimulation test).

You may not qualify if:

• History of diabetes Type 1 or 2.
• Biochemical evidence of impaired hepatic or renal function.
• History of cardiovascular disease.
• Uncontrolled hypertension.
• Current inflammatory or malignant disease.
• Pregnancy.

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charite Campus Benjamin Franklin

Berlin, 12200, Germany

Location

Related Publications (1)

• Arafat AM, Mohlig M, Weickert MO, Schofl C, Spranger J, Pfeiffer AF. Improved insulin sensitivity, preserved beta cell function and improved whole-body glucose metabolism after low-dose growth hormone replacement therapy in adults with severe growth hormone deficiency: a pilot study. Diabetologia. 2010 Jul;53(7):1304-13. doi: 10.1007/s00125-010-1738-4. Epub 2010 Apr 6.

  PMID: 20372873 DERIVED

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Growth Hormone; Human Growth Hormone

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ayman M Arafat, Dr.med.

  Charite Campus Benjamin Franklin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 29, 2009
• First Posted: June 30, 2009
• Study Start: November 1, 2003
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: June 30, 2009

Record last verified: 2009-06

Locations

DE (1)