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Growth Factor/Insulin-like Growth Factor (GH/IGF)-1 Axis in Obese Subjects in Treatment With Orlistat

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00991926
First Posted: October 8, 2009
Last Update Posted: October 14, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federico II University
  Purpose
The beneficial effects on plasma lipids of Orlistat, a selective gastrointestinal lipase inhibitor, are largely independent of weight loss, and might include differential effects plasma non-esterified fatty acid (NEFA). Apart from their well-known effects on insulin resistance pathogenesis, elevated NEFA levels probably play also the most important role at peripheral levels in the pathogenesis of Growth Hormone (GH) insufficiency in obesity. Aim of this observational, mono-centre, randomized, simple-blind, cross-over study is to verify if the short-term treatment with Orlistat may results in decline in NEFA circulating levels when used in conjunction with low-fat diet and if this effect may restore the endogenous activity of GH/ Insulin-like growth factor (IGF)-1 axis, in the context of GH regulation of lipoprotein metabolism, thus adding a further benefit of Orlistat in obesity cross-linked neuroendocrine and metabolic dearrangement.

Condition Intervention Phase
Obesity Drug: Orlistat Other: normo-caloric diet Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Evaluation of Baseline and Stimulated GH/IGF-1 AXIS in Obese Subjects in Treatment With Orlistat

Resource links provided by NLM:


Further study details as provided by Federico II University:

Primary Outcome Measures:
  • GH/IGF-1 axis (GH at baseline and after GHRH+Arg; IGF-1, IGFBP3, IGF-1/IGFBP3 ratio) [ Time Frame: 20 days ]

Secondary Outcome Measures:
  • fasting lipaemia (total, HDL and LDL cholesterol, tryglycerides, NEFA, total/HDL cholesterol ratio [ Time Frame: 20 days ]
  • post-prandial lipaemia (total, HDL and LDL cholesterol, tryglycerides, NEFA) [ Time Frame: 20 days ]
  • Antropometric indexes: Body mass index (BMI), waist circumference [ Time Frame: 20 days ]
  • glucose metabolism: OGTT, Insulin resistance (HOMA-R - homeostasis model assessment of insulin resistance) index, Insulin Sensitivity Index (ISI) [ Time Frame: 20 days ]

Enrollment: 20
Study Start Date: December 2006
Study Completion Date: February 2009
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
orlistat plus normo-caloric diet
10 subjects received normo-caloric diet plus + orlistat (Xenical, Roche, UK) at a dose of 120 mg tid. The duration of follow-up was 10 days
Drug: Orlistat
orlistat (Xenical, Roche, UK)120 mg tid
Other Name: gastrointestinal lipase inhibitor
Other: normo-caloric diet
Food intake and dietary history were assessed by a skilled dietitian who used a computer-assisted interview (Winfood 1.5, Medimatica srl, Martinsicuro, Italy)
normo-caloric diet
10 subjects received normo-caloric diet without the additional treatment. The duration of follow-up was 10 days
Other: normo-caloric diet
Food intake and dietary history were assessed by a skilled dietitian who used a computer-assisted interview (Winfood 1.5, Medimatica srl, Martinsicuro, Italy)

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
nondiabetic obese post-menopausal women
Criteria

Inclusion Criteria:

  • women
  • post-menopausal age
  • class I-II obesity
  • normal thyroid, liver, and kidney function

Exclusion Criteria:

  • type 2 diabetes mellitus
  • use of hypolipaemic agents
  Contacts and Locations
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): NCT00991926


Sponsors and Collaborators
Federico II University
Investigators
Principal Investigator: Annamaria Colao, MD, PhD Department of Molecular and Clinical Endocrinology and Oncology Federico II University of Naples
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Annamaria Colao, Dept of Moll Clin Endocrinol Oncol, University Federico II of Naples
ClinicalTrials.gov Identifier: NCT00991926     History of Changes
Other Study ID Numbers: NeuroendoUnit-12
First Submitted: October 7, 2009
First Posted: October 8, 2009
Last Update Posted: October 14, 2009
Last Verified: October 2009

Keywords provided by Federico II University:
obesity
GH/IGF-1 axis
postprandial NEFA

Additional relevant MeSH terms:
Orlistat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents