Clinical trial NCT02412774: Effects of Replacing Diet Beverages With Water on Weight Loss and Plasma Glucose Control in Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Overweight
Obese
Keywords: diet beverages
water
diabetes
weight loss
insulin sensitivity
Lead sponsor: Novindiet Clinic
Sponsor class: OTHER
Collaborators: name: University of Nottingham
name: Tehran University of Medical Sciences
First posted: 2015-04-09
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Weight loss
timeFrame: 24 weeks
Secondary outcomes:
measure: Fasting plasma glucose
timeFrame: 24 weeks
measure: Insulin resistance (HOMA)
timeFrame: 24 weeks
measure: Lipid profiles
timeFrame: 24 weeks
measure: Waist circumference
timeFrame: 24 weeks
measure: BMI
timeFrame: 24 Weeks
measure: HA1C
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: NovinDiet Clinic
Study officials:
affiliation: NovinDiet Clinic, School of Life Sciences, The University of Nottingham
name: Hamid R Farshchi, MD, PhD
role: STUDY_CHAIR
affiliation: NovinDiet Clinic, School of Life Sciences, The University of Nottingham
name: Ameneh Madjd, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Life Sciences, The University of Nottingham
name: Ian A Macdonald, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Life Sciences, The University of Nottingham
name: Moira A Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Digestive Disease Research Institute, Tehran University of Medical Sciences
name: Reza Malekzadeh, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Digestive Disease Research Institute, Tehran University of Medical Sciences
name: Alireza Delavari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lohner S, Kuellenberg de Gaudry D, Toews I, Ferenci T, Meerpohl JJ. Non-nutritive sweeteners for diabetes mellitus. Cochrane Database Syst Rev. 2020 May 25;5(5):CD012885. doi: 10.1002/14651858.CD012885.pub2.