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

NCT ID: NCT03726762

Last Updated: 2018-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Overweight Obese

Keywords

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diet beverages water diabetes weight loss insulin sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Diet Beverages

'Diet beverages' after the main meal

Group Type EXPERIMENTAL

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

Intervention Type 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

'Water' after the main meal

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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DBs 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.

Intervention Type BEHAVIORAL

Water 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Nottingham

OTHER

Sponsor Role collaborator

Tehran University of Medical Sciences

OTHER

Sponsor Role collaborator

Novindiet Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hamid R Farshchi, MD, PhD

Role: STUDY_CHAIR

NovinDiet Clinic, School of Life Sciences, The University of Nottingham

Ameneh Madjd, Dr

Role: PRINCIPAL_INVESTIGATOR

NovinDiet Clinic, School of Life Sciences, The University of Nottingham

Ian A Macdonald, Prof.

Role: PRINCIPAL_INVESTIGATOR

School of Life Sciences, The University of Nottingham

Moira A Taylor, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Life Sciences, The University of Nottingham

Reza Malekzadeh, Prof.

Role: PRINCIPAL_INVESTIGATOR

Digestive Disease Research Institute, Tehran University of Medical Sciences

Alireza Delavari, MD

Role: PRINCIPAL_INVESTIGATOR

Digestive Disease Research Institute, Tehran University of Medical Sciences

Locations

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NovinDiet Clinic

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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ND-307

Identifier Type: -

Identifier Source: org_study_id