Diabetes Health, Residence and Metabolism in Asians: The DHRMA Study

ISRCTN	ISRCTN02839188
DOI	https://doi.org/10.1186/ISRCTN02839188
Secondary identifying numbers	6811

Submission date: 21/05/2010
Registration date: 21/05/2010
Last edited: 26/10/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Ruth Lambley- Burke
Scientific

Lyndon
West Bromwich
B71 4HJ
United Kingdom

Email	abc@123.com

Study information

Study design	Single centre randomised interventional prevention trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Prevention
Scientific title	Diabetes Health, Residence and Metabolism in Asians: The DHRMA Study
Study acronym	DRN 335 DHRMA
Study objectives	The DHRMA study will focus on testing two distinct hypotheses using two separate studies: 1. Glycaemic index study: 1.1. The glycaemic index (GI) of DHRMA basmati rice (KETT less than 35%) is lower than UK traditional basmati rice or UK Super Basmati (KETT greater than 40%) and comparable to unrefined rice from rural Gujarat (jya and mysuri kernels); and 1.2. The GI of DHRMA stone-ground flour is lower than UK white and brown and wholemeal chapatti flour, but comparable to hand-milled flour from rural India 2. Interventional study: We will test the hypothesis that intervention with a low GI, carbohydrate rich/low fat diet will result in favourable changes in metabolic, diabetes and CHD risk indices compared to a high GI, carbohydrate rich/low fat diet.
Ethics approval(s)	MREC approved (ref: 08/H1204/130)
Health condition(s) or problem(s) studied	Topic: Diabetes Research Network; Subtopic: Other; Disease: Diabetic Control, Metabolic
Intervention	The use of stone ground flour or rice with a low glycaemic index as compared to the use of flour or rice with a higher glycaemic index.
Intervention type	Other
Primary outcome measure	To determine whether the rice and chappati flour test foods (DHRMA) exhibit a more favourable outcome
Secondary outcome measures	1. To develop foods for DHRMA that mimic those available in rural Gujarat 2. Diabetes and macrovascular risk 3. Glycaemic index (GI)
Overall study start date	31/03/2009
Completion date	30/09/2010

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Planned sample size: 100; UK sample size: 100
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	31/03/2009
Date of final enrolment	30/09/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Lyndon

West Bromwich
B71 4HJ
United Kingdom

Sponsor information

Sandwell and West Birmingham Hospitals NHS Trust (UK)
Hospital/treatment centre

Lyndon
West Bromwich
B71 4HJ
England
United Kingdom

Website	http://www.swbh.nhs.uk/
"ROR"	https://ror.org/05mzf3276

Funders

Funder type

Charity

British Heart Foundation (BHF) (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): the_bhf, The British Heart Foundation, BHF
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	02/12/2011		Yes	No
Abstract results	results presented at European Atherosclerosis Society (EAS) Congress	01/07/2015		No	No

Editorial Notes

26/10/2018: Publication reference added.