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

Study Overview
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Brief Summary
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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.

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 + Diet
* Behavioral: Water at the end of the main meal+ Diet


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 (DBs)<br>Diet beverages after the main meal+ Diet | Behavioral: DBs at the end of the main meal + Diet<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 for 24 weeks.<br>|
| Experimental: Water<br>Water after the main meal+ Diet | Behavioral: Water at the end of the main meal+ Diet<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 for 24 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting plasma glucose |  | 24 weeks | 
| Insulin resistance (HOMA) |  | 24 weeks | 
| Lipid profiles |  | 24 weeks | 
| Waist circumference |  | 24 weeks | 
| BMI |  | 24 Weeks | 
| HA1C |  | 24 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