A clinical trial to compare the patient outcomes from usual nutrition therapy by dietitians in India to patient outcomes from guideline-based medical nutrition therapy.
- Conditions
- Health Condition 1: null- Type 2 Diabetes Mellitus
- Registration Number
- CTRI/2013/01/003282
- Lead Sponsor
- Academy of Nutrition and Dietetics Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 600
Must be over 19 years of age
Must have medical diagnosis for treatment of type 2 Diabetes Mellitus,
Patient must agree to return for follow-up visits (or data collection visit) during the 12 months study period
Not seen by dietitian for one year prior to being recruited to the study
Currently being seen by dietitian for medical nutrition counselling
Participated in nutritional consults with dietitian in past year
Having insulin prescribed for Diabetes Mellitus treatment at time of recruitment
Pregnant or lactating at time of study
History of end stage renal disease or renal insufficiency; history of Cardiovascular accident, Coronary artery disease or Myocardial infarction; Chronic obstructive pulmonary disease; Congestive heart failure; untreated depression; severe psychiatric illness; cancer diagnosis in previous two years or on-going radiation or chemotherapy treatment
•Unplanned surgery requiring more than one overnight stay in the hospital within the previous week to initial visit
•The presence of cognitive or physical limitations that preclude making lifestyle or dietary changes as assessed by the registered dietitian during the initial interview
•Unable to return to office for data collection at 6 and 12 months and unable to commit to follow-up visits as per evidence based nutrition practice guidelines and dietitians recommendations.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hemoglobin A1C decreaseTimepoint: Baseline, 6 months, 12 months
- Secondary Outcome Measures
Name Time Method Change in Medications: <br/ ><br>Reduction in Diabetes relatedmedications treating hypoglycemia, <br/ ><br>Change in dosages of medications to treat high blood pressure and lipids. <br/ ><br>Timepoint: 6 month and 12 month;Lipid PanelTimepoint: 6 Month and 12 month;Self Monitoring DataTimepoint: 6 month and 12 month;Weight changeTimepoint: 6 month and 12 month