Bioimpedance Analysis for Follow-up of Dieters

Obesity Clinical Trial

— BIA  

Official title:

Abdominal Bioelectric Impedance for Follow-up of Dieters: A Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02975427
• Other study ID #: KA12/192
• Status: Completed
• Phase: N/A
• First received: October 27, 2016
• Last updated: November 28, 2016
• Start date: December 2011
• Est. completion date: March 2014

Study information

• Verified date: November 2016
• Source: Baskent Univesity Ankara Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Prospective, single arm, dietary intervention study.

Description:

This prospective study was conducted during the period from December 2011 through June 2013 in the Department of Endocrinology and Metabolism of Başkent University.

We enrolled 185 participants who were admitted to hospital for weight loss therapy. After initial evaluation, all participants were prescribed an appropriate diet with caloric restriction and an exercise program and underwent a follow-up examination 3±1 months later. At the end of the follow up, 103 participants attended to the research. Anthropometric, bioimpedance and laboratory measurements performed at baseline and second visit. We calculated the difference in anthropometric, bioimpedance and laboratory measurements between the first and second evaluations. Correlation analysis, multivariate linear regression analysis and receiver operating characteristic analysis performed to assess associations of laboratory metabolic variables with a decrease in anthropometric and bioimpedance analysis (BIA) measures, after diet and/or exercise therapy. The secondary aim was to determine whether abdominal BIA was better than simple anthropometric measurements and conventional BIA for assessing changes in metabolic variables.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: March 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Participants aged 18 to 70 years without chronic disease, cancer, a pacemaker, cardiac valve replacement, malabsorption syndrome, previous history of gastrointestinal surgery, thyroid disease, pregnancy, or a history of surgery during the previous 3 months.

Exclusion Criteria:

• Participants receiving oral antidiabetic drugs, insulin, any treatment for obesity, steroids or hormonal drugs, over-the-counter drugs for weight loss, any kind of phytodrug, or any drug that could affect glucose metabolism. We also excluded patients who used any of these drugs after the initial evaluation.

• Participants who, at the second visit, reported that they failed to adhere to the diet.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Diet group
All participants were prescribed an appropriate diet with caloric restriction and an exercise program and underwent a follow-up examination 3±1 months later.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baskent Univesity Ankara Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Value of abdominal BIA for the follow up of dieting individual		3 months (plus or minus 1 month)	No