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Completed

NCT Number: NCT02412774

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

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.

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Key information

Conditions

Type 2 Diabetes Body Weight Body Weight Changes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obese Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NovinDiet Clinic

Tehran, 1913635136, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DBs at the end of the main meal + Diet

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Weight loss

    Time frame: 24 weeks

Secondary outcomes

  1. Fasting plasma glucose

    Time frame: 24 weeks

  2. Insulin resistance (HOMA)

    Time frame: 24 weeks

  3. Lipid profiles

    Time frame: 24 weeks

  4. Waist circumference

    Time frame: 24 weeks

  5. BMI

    Time frame: 24 Weeks

  6. HA1C

    Time frame: 24 Weeks

Sponsors and collaborators

Lead sponsor

Novindiet Clinic

Other

Collaborators

  • Tehran University of Medical Sciences
  • University of Nottingham

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Apr 9, 2015
Registry last updated
Oct 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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