Effects of Replacing Diet Beverages With Water on Weight Loss and Plasma Glucose Control in Type 2 Diabetes

Not Applicable

Completed

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

• Registration Number: NCT02412774
• Lead Sponsor: Novindiet Clinic

Brief Summary

The purpose of the present study is to evaluate the effect of replacing diet beverages with water on weight loss and biochemical indicators for insulin sensitivity and cardiometabolic risk factors of diabetic obese and overweight female adults when they are in a multidisciplinary weight loss plan.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-06
• Study First Submitted QC: 2015-04-06
• Study First Posted: 2015-04-09
• Primary Completion: 2015-10
• Study Completion: 2016-01
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-24
• Last Update Posted: 2019-10-25

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
Diet Beverages (DBs)	DBs at the end of the main meal + Diet	Diet beverages after the main meal+ Diet
Water	Water at the end of the main meal+ Diet	Water after the main meal+ Diet

Primary Outcome Measures

Name	Time	Method
Weight loss	24 weeks

Secondary Outcome Measures

Name	Time	Method
HA1C	24 Weeks
Fasting plasma glucose	24 weeks
Waist circumference	24 weeks
Insulin resistance (HOMA)	24 weeks
Lipid profiles	24 weeks
BMI	24 Weeks

Trial Locations

Locations (1)

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