Influence of Obstructive Sleep Apnea on Metabolism and Weight Loss in Obese Individuals

Obesity Clinical Trial

Official title:

Influence of Obstructive Sleep Apnea on Metabolism and Weight Loss in Obese Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01985035
• Other study ID #: RMR-PRO
• Status: Completed
• Phase: N/A
• First received: November 4, 2013
• Last updated: July 1, 2016
• Start date: October 2013
• Est. completion date: August 2015

Study information

• Verified date: July 2016
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

Obstructive sleep apnea (OSA) can impars body weight reduction by changes in body composition and energy expenditure. The objective of this study is to evaluate the influence of OSA in energy metabolism and body mass loss in obese subjects. Ninety obese volunteers of both genders, 45 diagnosed with OSA and 45 without OSA, will be submitted to a dietary intervention of one months. Volunteers will be distributed into four groups: obese OSA PTN with moderate protein diet (1.6 g / kg protein / day), obese OSA CHO diet (0.8 g / kg protein / day) with standard composition diet, obese NSAOS PTN diet moderate in protein and CHO NSAOS obese standard diet. All groups will be instructed to perform a restricted energy diet (less 30% of daily energy expenditure). At baseline and one month after the beginning of the program the following evaluations will be conducted: total energy expenditure measured by doubly labeled water method, resting energy expenditure and thermic effect of food by calorimetry, polysomnography analysis, body composition by pletysmography, food consumption by three days of food diary, blood collection for analysis of lipid profile, visceral proteins, hormones related to control of body weight and inflammation. As hypothesis we believe that apneic obese individuals have greater difficult in weight loss and loss more free fat mass than the obese no apneic and that diets with more protein can contribute to greater weight loss, better body composition and energy expenditure in these population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• Body Mass Index between 30 and 40 kg/m2;

• Obstructive sleep apnea mild or severe;

• Sedentary.

Exclusion Criteria:

• Intake of any drug that interfere on metabolism such for thyroid or to lose weight;

• Be engaged in other treatment for sleep apnea or obesity;

• Present another sleep disorder;

• Being shift work;

• Present any kind of kidney disease.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obesity
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• Diet
Reduction of energy intake in order to weight loss

Locations

Country	Name	City	State
Brazil	Departamento de Psicobiologia - Universidade Federal de São Paulo	São Paulo
Brazil	Universidade Federal de São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy expenditure	Measurements of energy expenditure by doubly labeled water for day energy expenditure and by calorimetry for resting energy expenditure and thermic effect of food	up to 4 months	Yes
Secondary	Body Composition	Bodu composition evaluation by pletismografy to determine fat mass and fat free mass	Baseline, 1 month, 2 months and 4 months	Yes