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

Type 2 Diabetes Clinical Trial

Official title:

Effects of Replacing Diet Beverages With Water on Type 2 Diabetic Obese Females Attending a Weight Loss Program - a Randomized, 24 Week Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02412774
• Other study ID #: ND-107
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: January 2016

Study information

• Verified date: October 2019
• Source: Novindiet Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: January 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obese
• Overweight
• Type 2 Diabetes
• Weight Loss

Intervention

Behavioral:
• DBs at the end of the main meal + Diet
Subjects are asked to have 250 ml DBs at the end of their lunch as the main meal, while they are on a multidisciplinary diet plan for 24 weeks.
• Water at the end of the main meal+ Diet
Subjects are asked to have 250 ml water at the end of their lunch as the main meal, while they are on a multidisciplinary diet plan for 24 weeks.

Locations

Country	Name	City	State
Iran, Islamic Republic of	NovinDiet Clinic	Tehran

Sponsors (3)

Lead Sponsor	Collaborator
Novindiet Clinic	Tehran University of Medical Sciences, University of Nottingham

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss		24 weeks
Secondary	Fasting plasma glucose		24 weeks
Secondary	Insulin resistance (HOMA)		24 weeks
Secondary	Lipid profiles		24 weeks
Secondary	Waist circumference		24 weeks
Secondary	BMI		24 Weeks
Secondary	HA1C		24 Weeks