- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01703611
Diabetes in India Nutrition Guidelines Study (DINGS) (DINGS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Lucknow, India, 226014
- Sanjay Gandhi Post Graduate Institute
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Uttar Pradesh, India
- Fortis Hospital
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-
Andhra Pradesh
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Vijayawada, Andhra Pradesh, India, 520007
- Nagajuna Hospital
-
-
Assam
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Guwahati, Assam, India
- Barman Diabetes Specialties
-
-
Gujarat
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Amadavad, Gujarat, India, 380015
- Dia Care 1 & 2
-
-
Haryana
-
Faridabad, Haryana, India, 121007
- Fortis Escorts Hospital
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Faridabad, Haryana, India
- Asian Institute of Medical Sciences
-
-
Kerala
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Calicut, Kerala, India
- Malabar Institute of Medical Sciences
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Kottayam, Kerala, India
- Caritis Hospital
-
-
Maharashtra
-
Mumbai, Maharashtra, India
- BhaktiVedanta Hospital
-
-
Pradesh
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Hyderabad, Pradesh, India
- Star Hospitals
-
-
Rajasthan
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Jaipur, Rajasthan, India, 302015
- Santokba Durlabji Memorial Hospital
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-
Tamilnadu
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Chennai, Tamilnadu, India, 600040
- Sundaram Medical Foundation
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Coimbatore, Tamilnadu, India, 641004
- PSG Hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion and exclusion criteria for participant selection is listed both for the dietitians and patient participants.
Dietitian Participant
Inclusion Criteria:
- RD and Indian ICC CDE RD
Active practice (at least two years post-professional degree), with enough newly diagnosed type 2 DM patients or patients not seen by an RD for the previous year, to be able to recruit four to six of them into the study each week
- Work in an Diabetes centers and hospital diabetes outpatient or private practice with diabetologist to provide medical oversight for study
- Have written approval from immediate supervisor and diabetologist indicating that MNT visits can be provided without cost to research study in accordance with ADA EBNPG and data collection can be accommodated.
- Have computer and internet access. Minimum requirements are Microsoft Internet Explorer 8.0 with 1024 x 768 screen resolution in 256 colors. The browser must be enabled for Java, JavaScript and cookies
- Have stable internet connection (no prolonged periods without or frequent disruptions in internet service
- Have land phone line and faxing capabilities
- Able to provide data documentation electronically or in a paper format
- Obtain approval from their facility's Independent Ethics Committee (equivalent to US Institutional Review Board) for participation in the study (if required by the institution)
- Able to adjust the institution's habitual counseling session schedule and duration as required by the study protocol
- Commit to attendance during the full course of face to face training for three days (including part of a weekend), to be held at Chennai, India, and participate in the Webinars and conference calls
Exclusion criteria:
- Small clientele of adult type 2 DM,
- Fewer than two years' active clinical practice experience post-professional degree,
- Unable to comply with the other inclusion criteria (see inclusion section above).
Patient Participant
Patients' Inclusion Criteria:
- Must be over 19 years of age
- Must have medical diagnosis for treatment of type 2 DM,
- Patient must agree to return for follow-up visits (or data collection visit) during the 12 months study period
- Not seen by RD for one year prior to being recruited to the study
Patients' Exclusion Criteria:
- Currently being seen by RD for MNT
- Participated in nutritional consults with RD in past year
- Having insulin prescribed for DM treatment at time of recruitment
- Pregnant or lactating at time of study
- History of end stage renal disease or renal insufficiency; history of CVA, CAD or MI; COPD; CHF; 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 RD 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 for EBNPG.
Patient Dis-enrollment or Stop Point for Study Participation
Patient will no longer be in the study after he/she reports the onset of:
- End stage renal disease or renal insufficiency;
- CVA, CAD or MI;
- COPD;
- Depression, severe psychiatric illness;
- Cancer diagnosis and treatment;
- CHF;
- Unplanned surgery requiring more than one overnight stay in the hospital within the previous week;
- Pregnant,
- Any onset of cognitive or physical limitations that preclude making lifestyle or dietary changes per RD assessment during study period,
- Other acute/chronic complications that could exacerbate the patient's diabetic condition or general well-being.
- Physician starts injectable insulin therapy
Study Plan
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: MNT according to AND EBNPG for Type 2 DM
Six or more Medical Nutrition Therapy visits(education and counseling on diet, self management, and lifestyle changes) provided over a 12 month period according to Academy of Nutrition and Dietetic Evidence Based Nutrition Practice Guidelines (EBPGN) (www.guidelines.gov)
|
Six or more Medical Nutrition Therapy visits(education and counseling on diet, self management, and lifestyle changes) provided over a 12 month period according to Academy of Nutrition and Dietetic Evidence Based Nutrition Practice Guidelines (EBNPG)(www.guidelines.gov)
Other Names:
|
Active Comparator: Usual Nutrition Care
Visits for usual nutrition therapy (diet and lifestyle changes) provided by dietitians over a 12 month period.
|
Usual nutrition care in India
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HbAIc decrease
Time Frame: 6 months and 12 months
|
6 months and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Weight change
Time Frame: 6 month and 12 month
|
6 month and 12 month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lipid panel
Time Frame: 6 month and 12 month
|
Total Cholesterol, LDL Cholesterol, HDL Cholesterol and Triglycerides
|
6 month and 12 month
|
Blood pressure
Time Frame: 6 months and 12 months
|
Systolic and Diastolic change from baseline measure
|
6 months and 12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Esther F Myers, PhD, Academy of Nutrition and Dietetics
- Principal Investigator: Varsha (none), PhD, Shri Shradda Hospital
- Principal Investigator: Naomi Trostler, PhD, Hebrew University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Academy-India-1
- IINS-ANDF/2011/01 (Other Identifier: India Clinical Trial Registry)
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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