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

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: NCT03726762
• Other study ID #: ND-307
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: June 2017

Study information

• Verified date: October 2018
• Source: Novindiet Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: June 2017
• Est. primary completion date: February 2017
• 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

• Obese
• Overweight
• Type 2 Diabetes

Intervention

Behavioral:
• DBs at the end of the main meal + weight control program
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.
• Water at the end of the main meal+ weight control program
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.

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