Diabetes Health, Residence and Metabolism in Asians: The DHRMA Study
| ISRCTN | ISRCTN02839188 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02839188 |
| Protocol serial number | 6811 |
| Sponsor | Sandwell and West Birmingham Hospitals NHS Trust (UK) |
| Funder | British Heart Foundation (BHF) (UK) |
- 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
Scientific
Lyndon
West Bromwich
B71 4HJ
United Kingdom
| abc@123.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre randomised interventional prevention trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
To determine whether the rice and chappati flour test foods (DHRMA) exhibit a more favourable outcome |
| Key secondary outcome measure(s) |
1. To develop foods for DHRMA that mimic those available in rural Gujarat |
| Completion date | 30/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Lyndon
West Bromwich
B71 4HJ
United Kingdom
B71 4HJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
