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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes, Overweight, Obese

Intervention / Treatment
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* Behavioral: DBs at the end of the main meal + weight control program
* Behavioral: Water at the end of the main meal+ weight control program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet Beverages<br>'Diet beverages' after the main meal | Behavioral: DBs at the end of the main meal + weight control program<br>* 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.<br>|
| Experimental: Water<br>'Water' after the main meal | Behavioral: Water at the end of the main meal+ weight control program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss |  | 77 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting plasma glucose |  | 77 weeks | 
| Insulin resistance (HOMA) |  | 77 weeks | 
| Lipid profiles |  | 77 weeks | 
| Waist circumference |  | 77 weeks | 
| BMI |  | 77 Weeks | 
| HA1C |  | 77 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diet beverages, water, diabetes, weight loss, insulin sensitivity