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

Effects of Replacing Diet Beverages With Water on Type 2 Diabetic Obese Females Attending a Weight Loss Program - a Randomized, 24 Week Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03726762
Enrollment
81
Registered
2018-10-31
Start date
2015-04-30
Completion date
2017-06-30
Last updated
2018-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese, Overweight, Type 2 Diabetes

Keywords

diet beverages, water, diabetes, weight loss, insulin sensitivity

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.

Interventions

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

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.

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

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.

Sponsors

University of Nottingham
CollaboratorOTHER
Tehran University of Medical Sciences
CollaboratorOTHER
Novindiet Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Weight loss77 weeks

Secondary

MeasureTime frame
Insulin resistance (HOMA)77 weeks
Lipid profiles77 weeks
Fasting plasma glucose77 weeks
BMI77 Weeks
HA1C77 Weeks
Waist circumference77 weeks

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026