MedTrace Logo

A Study to Characterise the Physiology of Weight Loss and Regain Under Dietary, Behavioural and Pharmacological Interventions in Healthy Obese Subjects

NCT01597609 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-06-20

No results posted yet for this study

Summary

Approximately 60 obese, but otherwise healthy, subjects will be assessed in this benchmark study to investigate the physiological changes associated with weight loss and regain. The aim is to estimate the changes in body composition during and after three interventions (i) calorie restricted diet + a marketed anti-obesity drug (sibutramine )(ii) calorie restricted diet + sibutramine placebo, and (iii) calorie restricted diet + moderate exercise. The interventions will last 12 weeks, after which there is a further 12 week observation period during which subjects will return to their normal lifestyle and are expected to regain weight. Additionally, a range of biomarkers may be evaluated to determine whether there are correlations at early and late time points with weight and fat loss and weight and fat regain. The changes in body composition and other biomarkers will be used to determine whether mathematical models can be built that predict the weight loss and regain of individual subjects. In addition, the usefulness of tools that may aid the physiological characterisation of weight loss/regain will be assessed, in particular methods for measuring energy expenditure and energy intake such as ambulatory activity meter, Sussex Ingestion Pattern Monitor ™ (SIPM), hunger-satiety VAS, indirect calorimetry and, if available, the Theranos in-home graphical user interface (GUI) portal. Knowledge of the body composition changes resulting from these typical weight loss interventions and predictive markers of response would facilitate the design of future studies for novel anti-obesity agents and allow earlier, more informed triaging of NCEs.

Conditions

Interventions

DRUG

sibutramine

10 mg, taken orally once per day for 12 weeks

OTHER

sibutramine placebo

taken orally once per day for 12 weeks

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-22
Primary Completion
2010-03-04
Completion
2010-03-04

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01597609 on ClinicalTrials.gov