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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02412774 |
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Date of registration:
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06/04/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects of Replacing Diet Beverages With Water on Weight Loss and Plasma Glucose Control in Type 2 Diabetes
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Scientific title:
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Effects of Replacing Diet Beverages With Water on Type 2 Diabetic Obese Females Attending a Weight Loss Program - a Randomized, 24 Week Clinical Trial |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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81 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02412774 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Iran, Islamic Republic of
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Contacts
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Name:
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Alireza Delavari, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Digestive Disease Research Institute, Tehran University of Medical Sciences |
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Name:
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Reza Malekzadeh, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Digestive Disease Research Institute, Tehran University of Medical Sciences |
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Name:
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Hamid R Farshchi, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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NovinDiet Clinic, School of Life Sciences, The University of Nottingham |
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Name:
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Ian A Macdonald, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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School of Life Sciences, The University of Nottingham |
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Name:
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Ameneh Madjd, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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NovinDiet Clinic, School of Life Sciences, The University of Nottingham |
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Name:
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Moira A Taylor, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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School of Life Sciences, The University of Nottingham |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diabetic female patient with 6.5
- 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.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes
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Obese
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Overweight
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Intervention(s)
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Behavioral: DBs at the end of the main meal + Diet
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Behavioral: Water at the end of the main meal+ Diet
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Primary Outcome(s)
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Weight loss
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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Fasting plasma glucose
[Time Frame: 24 weeks]
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Waist circumference
[Time Frame: 24 weeks]
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Insulin resistance (HOMA)
[Time Frame: 24 weeks]
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Lipid profiles
[Time Frame: 24 weeks]
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BMI
[Time Frame: 24 Weeks]
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HA1C
[Time Frame: 24 Weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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