Diabetes in India Nutrition Guidelines Study (DINGS)

Type 2 Diabetes Mellitus Clinical Trial

— DINGS  

Official title:

Diabetes in India Nutrition Guidelines Study (DINGS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01703611
• Other study ID #: Academy-India-1
• Secondary ID: IINS-ANDF/2011/0
• Status: Completed
• Phase: N/A
• First received: October 6, 2012
• Last updated: February 18, 2016
• Start date: December 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2016
• Source: Academy of Nutrition and Dietetics
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Other:
• 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 (EBNPG)(www.guidelines.gov)
• Usual Nutrition Care
Usual nutrition care in India

Locations

Country	Name	City	State
India	Dia Care 1 & 2	Amadavad	Gujarat
India	Malabar Institute of Medical Sciences	Calicut	Kerala
India	Sundaram Medical Foundation	Chennai	Tamilnadu
India	PSG Hospitals	Coimbatore	Tamilnadu
India	Asian Institute of Medical Sciences	Faridabad	Haryana
India	Fortis Escorts Hospital	Faridabad	Haryana
India	Barman Diabetes Specialties	Guwahati	Assam
India	Star Hospitals	Hyderabad	Pradesh
India	Santokba Durlabji Memorial Hospital	Jaipur	Rajasthan
India	Caritis Hospital	Kottayam	Kerala
India	Sanjay Gandhi Post Graduate Institute	Lucknow
India	BhaktiVedanta Hospital	Mumbai	Maharashtra
India	Fortis Hospital	Uttar Pradesh
India	Nagajuna Hospital	Vijayawada	Andhra Pradesh

Sponsors (4)

Lead Sponsor	Collaborator
Academy of Nutrition and Dietetics	Abbott Healthcare Private Limited (in India), Academy of Nutrition and Dietetics Foundation, Indian Institute of Nutritional Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lipid panel	Total Cholesterol, LDL Cholesterol, HDL Cholesterol and Triglycerides	6 month and 12 month	No
Other	Blood pressure	Systolic and Diastolic change from baseline measure	6 months and 12 months	No
Primary	HbAIc decrease		6 months and 12 months	No
Secondary	Weight change		6 month and 12 month	No