NCT00991926

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2006

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2009

Completed
Last Updated

October 14, 2009

Status Verified

October 1, 2009

Enrollment Period

Same day

First QC Date

October 7, 2009

Last Update Submit

October 13, 2009

Conditions

Obesity

Keywords

obesityGH/IGF-1 axispostprandial NEFA

Outcome Measures

Primary Outcomes (1)

  • GH/IGF-1 axis (GH at baseline and after GHRH+Arg; IGF-1, IGFBP3, IGF-1/IGFBP3 ratio)

    20 days

Secondary Outcomes (4)

  • fasting lipaemia (total, HDL and LDL cholesterol, tryglycerides, NEFA, total/HDL cholesterol ratio

    20 days

  • post-prandial lipaemia (total, HDL and LDL cholesterol, tryglycerides, NEFA)

    20 days

  • Antropometric indexes: Body mass index (BMI), waist circumference

    20 days

  • glucose metabolism: OGTT, Insulin resistance (HOMA-R - homeostasis model assessment of insulin resistance) index, Insulin Sensitivity Index (ISI)

    20 days

Study Arms (2)

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: OrlistatOther: 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

Interventions

OrlistatDRUG

orlistat (Xenical, Roche, UK)120 mg tid

Also known as: gastrointestinal lipase inhibitor
orlistat plus normo-caloric diet
normo-caloric dietOTHER

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 dietorlistat plus normo-caloric diet

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

nondiabetic obese post-menopausal women

You may qualify if:

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

You may not qualify if:

  • type 2 diabetes mellitus
  • use of hypolipaemic agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Di Somma C, Rivellese A, Pizza G, Patti L, De Rosa A, Cipriano P, Nedi V, Rossi A, Lombardi G, Colao A, Savastano S. Effects of short-term treatment with orlistat on growth hormone/insulin-like growth factor-I axis in obese post-menopausal women. J Endocrinol Invest. 2011 Feb;34(2):90-6. doi: 10.1007/BF03347036.

    PMID: 21502796DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Orlistat

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LactonesOrganic Chemicals

Study Officials

  • Annamaria Colao, MD, PhD

    Department of Molecular and Clinical Endocrinology and Oncology Federico II University of Naples

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 7, 2009

First Posted

October 8, 2009

Study Start

December 1, 2006

Primary Completion

December 1, 2006

Study Completion

February 1, 2009

Last Updated

October 14, 2009

Record last verified: 2009-10