- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03726762
Effects of Replacing Diet Beverages With Water on Weight Maintenance of Type 2 Diabetic Obese Women: 18 Months Follow up
October 30, 2018 updated by: Novindiet Clinic
Effects of Replacing Diet Beverages With Water on Type 2 Diabetic Obese Females Attending a Weight Loss Program - a Randomized, 24 Week Clinical Trial
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
81
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of, 1913635136
- NovinDiet Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diet Beverages
'Diet beverages' after the main meal
|
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.
|
Experimental: Water
'Water' after the main meal
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Weight loss
Time Frame: 77 weeks
|
77 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fasting plasma glucose
Time Frame: 77 weeks
|
77 weeks
|
Insulin resistance (HOMA)
Time Frame: 77 weeks
|
77 weeks
|
Lipid profiles
Time Frame: 77 weeks
|
77 weeks
|
Waist circumference
Time Frame: 77 weeks
|
77 weeks
|
BMI
Time Frame: 77 Weeks
|
77 Weeks
|
HA1C
Time Frame: 77 Weeks
|
77 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Hamid R Farshchi, MD, PhD, NovinDiet Clinic, School of Life Sciences, The University of Nottingham
- Principal Investigator: Ian A Macdonald, Prof., School of Life Sciences, The University of Nottingham
- Principal Investigator: Moira A Taylor, PhD, School of Life Sciences, The University of Nottingham
- Principal Investigator: Reza Malekzadeh, Prof., Digestive Disease Research Institute, Tehran University of Medical Sciences
- Principal Investigator: Alireza Delavari, MD, Digestive Disease Research Institute, Tehran University of Medical Sciences
- Principal Investigator: Ameneh Madjd, Dr, NovinDiet Clinic, School of Life Sciences, The University of Nottingham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2015
Primary Completion (Actual)
February 1, 2017
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
October 30, 2018
First Submitted That Met QC Criteria
October 30, 2018
First Posted (Actual)
October 31, 2018
Study Record Updates
Last Update Posted (Actual)
October 31, 2018
Last Update Submitted That Met QC Criteria
October 30, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ND-307
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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