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Type 2 Diabetes MellitusDINGSNCT01703611

Diabetes in India Nutrition Guidelines Study (DINGS)

A study testing MNT according to AND EBNPG for Type 2 DM and Usual Nutrition Care in people with Type 2 Diabetes Mellitus, run by Academy of Nutrition and Dietetics at 14 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
MNT according to AND EBNPG for Type 2 DM and Usual Nutrition Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
238 participants
Where
14 sitesIndia
Study dates
Dec 2012to Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

India14 sites

  • Dia Care 1 & 2

    Ahmedabad, Gujarat, 380015

  • Malabar Institute of Medical Sciences

    Calicut, Kerala

  • Sundaram Medical Foundation

    Chennai, Tamil Nadu, 600040

  • PSG Hospitals

    Coimbatore, Tamil Nadu, 641004

  • Fortis Escorts Hospital

    Faridabad, Haryana, 121007

  • Asian Institute of Medical Sciences

    Faridabad, Haryana

  • Barman Diabetes Specialties

    Guwahati, Assam

  • Star Hospitals

    Hyderabad, Pradesh

  • Santokba Durlabji Memorial Hospital

    Jaipur, Rajasthan, 302015

  • Caritis Hospital

    Kottayam, Kerala

  • Sanjay Gandhi Post Graduate Institute

    Lucknow, 226014

  • BhaktiVedanta Hospital

    Mumbai, Maharashtra

  • Fortis Hospital

    Uttar Pradesh

  • Nagajuna Hospital

    Vijayawada, Andhra Pradesh, 520007

Other trials in India

About this study

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).

Read the 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)

Being tested
MNT according to AND EBNPG for Type 2 DM, Usual Nutrition Care
Keywords
Nutrition, Medical Nutrition Therapy, Diabetes Mellitus, Nutrition outcomes, Evidence Based Guidelines
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MNT according to AND EBNPG for Type 2 DMOther

    Also called Nutrition Counseling, Nutrition Care, Nutrition Therapy, Evidence Based Nutrition Practice

    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 CareOther

    Also called Nutrition Counselling, Nutrition Therapy

    Usual nutrition care in India

Study groups in NCT01703611
Study groupRoleWhat they receive
MNT according to AND EBNPG for Type 2 DMExperimentalSix 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)
Receives: Other: MNT according to AND EBNPG for Type 2 DM
Usual Nutrition CareActive comparatorVisits for usual nutrition therapy (diet and lifestyle changes) provided by dietitians over a 12 month period.
Receives: Other: Usual Nutrition Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbAIc decrease

    Measured: 6 months and 12 months

Secondary outcomes (1)

  1. Weight change

    Measured: 6 month and 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
238 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01703611
Sponsor's protocol ID
Academy-India-1
Other IDs
IINS-ANDF/2011/01
Acronym
DINGS
Status last verified
Feb 2016
First submitted
6 Oct 2012
Last updated
22 Feb 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing MNT according to AND EBNPG for Type 2 DM and Usual Nutrition Care in people with Type 2 Diabetes Mellitus, run by Academy of Nutrition and Dietetics at 14 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbAIc decrease (time frame: 6 months and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01703611.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2016.

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