Clinical trial NCT03726762: Effects of Replacing Diet Beverages With Water on Weight Maintenance of Type 2 Diabetic Obese Women: 18 Months Follow up
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: 2018-10-31
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 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.


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: 77 weeks
Secondary outcomes:
measure: Fasting plasma glucose
timeFrame: 77 weeks
measure: Insulin resistance (HOMA)
timeFrame: 77 weeks
measure: Lipid profiles
timeFrame: 77 weeks
measure: Waist circumference
timeFrame: 77 weeks
measure: BMI
timeFrame: 77 Weeks
measure: HA1C
timeFrame: 77 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: