Clinical trial NCT01703611: Diabetes in India Nutrition Guidelines Study (DINGS)
Official title: Diabetes in India Nutrition Guidelines Study (DINGS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Nutrition
Medical Nutrition Therapy
Diabetes Mellitus
Nutrition outcomes
Evidence Based Guidelines
Lead sponsor: Academy of Nutrition and Dietetics
Sponsor class: OTHER
Collaborators: name: Indian Institute of Nutritional Sciences
name: Abbott Healthcare Private Limited (in India)
First posted: 2012-10-10
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 (MNT).

Detailed description: A cluster randomized clinical trial to compare patient outcomes from two different nutrition interventions by dietitians in India for persons with Type 2 Diabetes Mellitus (usual care vs Medical Nutrition Therapy provided according to the Academy of Nutrition and Dietetics Evidence-Based Nutrition Practice Guidelines)

Eligibility criteria: 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

Primary outcomes:
measure: HbAIc decrease
timeFrame: 6 months and 12 months
Secondary outcomes:
measure: Weight change
timeFrame: 6 month and 12 month
Other outcomes:
measure: Lipid panel
timeFrame: 6 month and 12 month
measure: Blood pressure
timeFrame: 6 months and 12 months
Locations:
city: Vijayawada
country: India
facility: Nagajuna Hospital
state: Andhra Pradesh
city: Guwahati
country: India
facility: Barman Diabetes Specialties
state: Assam
city: Amadavad
country: India
facility: Dia Care 1 & 2
state: Gujarat
city: Faridabad
country: India
facility: Fortis Escorts Hospital
state: Haryana
city: Faridabad
country: India
facility: Asian Institute of Medical Sciences
state: Haryana
city: Calicut
country: India
facility: Malabar Institute of Medical Sciences
state: Kerala
city: Kottayam
country: India
facility: Caritis Hospital
state: Kerala
city: Mumbai
country: India
facility: BhaktiVedanta Hospital
state: Maharashtra
city: Hyderabad
country: India
facility: Star Hospitals
state: Pradesh
city: Jaipur
country: India
facility: Santokba Durlabji Memorial Hospital
state: Rajasthan
city: Chennai
country: India
facility: Sundaram Medical Foundation
state: Tamilnadu
city: Coimbatore
country: India
facility: PSG Hospitals
state: Tamilnadu
city: Lucknow
country: India
facility: Sanjay Gandhi Post Graduate Institute
city: Uttar Pradesh
country: India
facility: Fortis Hospital
Study officials:
affiliation: Academy of Nutrition and Dietetics
name: Esther F Myers, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shri Shradda Hospital
name: Varsha (none), PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hebrew University
name: Naomi Trostler, PhD
role: PRINCIPAL_INVESTIGATOR
References: