NCT02975427

Brief Summary

Prospective, single arm, dietary intervention study.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2011

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, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
Last Updated

November 29, 2016

Status Verified

November 1, 2016

Enrollment Period

1.5 years

First QC Date

October 27, 2016

Last Update Submit

November 28, 2016

Conditions

Keywords

DietAbdominal bioelectrical impedance analysisAnthropometryInsulin resistance

Outcome Measures

Primary Outcomes (1)

  • Value of abdominal BIA for the follow up of dieting individual

    3 months (plus or minus 1 month)

Study Arms (1)

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.

Other: Diet group

Interventions

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

Diet group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

One hundred and eighty five participants who were admitted to hospital for weight loss therapy enrolled to the study. 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. A total of 134 participants reported for the second visit; 51 did not. Thirty one participants who, at the second visit, reported that they failed to adhere to the diet were excluded from the analysis . Ultimately, data from 103 participants who reported that they adhered to the diet were included in the analysis.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Yusuf Bozkuş, Dr.

    Baskent University Ankara Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

October 27, 2016

First Posted

November 29, 2016

Study Start

December 1, 2011

Primary Completion

June 1, 2013

Study Completion

March 1, 2014

Last Updated

November 29, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share