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

Obesity Clinical Trial

Official title:
A Single-blind, Randomised, Placebo-controlled, Parallel Group, Incomplete Block Design, Benchmark Study to Characterise the Physiology of Weight Loss and Regain Under Dietary, Behavioural and Pharmacological Interventions in Healthy Obese Subjects

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01597609
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 1
Start date May 22, 2008
Completion date March 4, 2010
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