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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:
Information provided by:
Federico II University
ClinicalTrials.gov Identifier:
NCT00991926
First received: October 7, 2009
Last updated: October 13, 2009
Last verified: October 2009
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fasting lipaemia (total, HDL and LDL cholesterol, tryglycerides, NEFA, total/HDL cholesterol ratio [ Time Frame: 20 days ] [ Designated as safety issue: No ]
  • post-prandial lipaemia (total, HDL and LDL cholesterol, tryglycerides, NEFA) [ Time Frame: 20 days ] [ Designated as safety issue: No ]
  • Antropometric indexes: Body mass index (BMI), waist circumference [ Time Frame: 20 days ] [ Designated as safety issue: No ]
  • glucose metabolism: OGTT, Insulin resistance (HOMA-R - homeostasis model assessment of insulin resistance) index, Insulin Sensitivity Index (ISI) [ Time Frame: 20 days ] [ Designated as safety issue: No ]

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)
Other Name: normo-caloric diet
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)
Other Name: normo-caloric diet

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Federico II University

Additional 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
Study First Received: October 7, 2009
Last Updated: October 13, 2009
Health Authority: Italy: Ethics Committee
Italy: Ministry of Health
Italy: National Institute of Health

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

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Orlistat
Anti-Obesity Agents
Central Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014