Effects of Replacing Diet Beverages With Water on Weight Maintenance of Type 2 Diabetic Obese Women: 18 Months Follow up

Not Applicable

Completed

• Conditions: Overweight; Type 2 Diabetes; Obese
• Interventions: Behavioral: Water at the end of the main meal+ weight control program; Behavioral: DBs at the end of the main meal + weight control program

• Registration Number: NCT03726762
• Lead Sponsor: Novindiet Clinic

Brief Summary

the present study aimed to follow up our participants in order to consider the changes in weight and anthropometric measurements after the 12-month weight maintenance as well as the total of 18 months, consisting of the previously described 24 weeks active weight loss and a further 53 weeks weight maintenance. The secondary outcome was to compare the abdominal adiposity, carbohydrate, and lipid metabolism during these periods.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Primary Completion: 2017-02
• Study Completion: 2017-06
• Status Verified: 2018-10
• Study First Submitted: 2018-10-30
• Study First Submitted QC: 2018-10-30
• Last Update Submitted: 2018-10-30
• Study First Posted: 2018-10-31
• Last Update Posted: 2018-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 81

Inclusion Criteria

• Diabetic female patient with 6.5<H1AC<7.2.
• Monotherapy with Metformin.
• 18-45 years of age.
• Body mass index (BMI) between 27-35 kg/ m².
• Consume DBs regularly during their habitual diet.
• Must be able to have moderate exercise.
• Must be interested to have weight loss.

Exclusion Criteria

• Participating in a research project involving weight loss or physical activity in the previous six months.
• Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
• Taking medication that could affect metabolism or change body weight.
• Report heart problems, chest pain, and cancer within the last five years.
• Unwilling to change intake of beverages during the study period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Water	Water at the end of the main meal+ weight control program	'Water' after the main meal
Diet Beverages	DBs at the end of the main meal + weight control program	'Diet beverages' after the main meal

Primary Outcome Measures

Name	Time	Method
Weight loss	77 weeks

Secondary Outcome Measures

Name	Time	Method
Insulin resistance (HOMA)	77 weeks
BMI	77 Weeks
Fasting plasma glucose	77 weeks
Waist circumference	77 weeks
Lipid profiles	77 weeks
HA1C	77 Weeks

Trial Locations

Locations (1)

NovinDiet Clinic; 🇮🇷 Tehran, Iran, Islamic Republic of