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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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19 February 2015 |
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Main ID: |
NCT00729196 |
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Date of registration:
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05/08/2008 |
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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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A Trial of Two Diets for Weight and Diabetes Management
Two-for-2 |
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Scientific title:
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A Trial of Two Diets for Weight and Diabetes Management |
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Date of first enrolment:
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July 2005 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00729196 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Thomas A Wadden, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Pennsylvania |
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Name:
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Stanley Schwartz, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Pennsylvania |
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Name:
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Virginia A Stallings, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital of Philadelphia |
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Name:
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Anthony N Fabricatore, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Pennsylvania |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Type 2 Diabetes Mellitus
- Body mass index (BMI) of 27 to 45 kg/m2 with weight
- Capacity to provide written informed consent
- Systolic blood pressure between 90 and 160 mm Hg, inclusive.
- Diastolic blood pressure between 65 and 100 mm Hg, inclusive.
- Resting heart rate between 65 and 90 beats per minute, inclusive.
Exclusion Criteria:
- a recent (i.e., within 1 year) myocardial infarction
- unstable angina
- malignant arrhythmias
- history of cerebrovascular, renal, or hepatic disease
- history of seizures
- protein wasting diseases (e.g., Cushing's syndrome)
- uncontrolled hypertension (> 160/100 mm Hg)
- type 1 diabetes
- uncontrolled thyroid disease
- pregnancy or lactation
- electrolyte abnormalities
- clinically significant psychosocial impairment (principally, major depression)
- treatment with steroids
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes Mellitus
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Obesity
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Intervention(s)
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Behavioral: Lifestyle Modification
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Primary Outcome(s)
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Percent change in weight
[Time Frame: 92 weeks]
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Secondary Outcome(s)
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Change in HbA1c
[Time Frame: 92 weeks]
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Secondary ID(s)
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K23 DK70777 (completed)
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K23 DK070777
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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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