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Completed

NCT Number: NCT03726762

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

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.

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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 + weight control program

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.

Water at the end of the main meal+ weight control program

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.

Primary outcomes

  1. Weight loss

    Time frame: 77 weeks

Secondary outcomes

  1. Fasting plasma glucose

    Time frame: 77 weeks

  2. Insulin resistance (HOMA)

    Time frame: 77 weeks

  3. Lipid profiles

    Time frame: 77 weeks

  4. Waist circumference

    Time frame: 77 weeks

  5. BMI

    Time frame: 77 Weeks

  6. HA1C

    Time frame: 77 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
2017
Study completion
2017
First posted
Oct 31, 2018
Registry last updated
Oct 31, 2018

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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