PMID- 33040003 OWN - NLM STAT- MEDLINE DCOM- 20210514 LR - 20221207 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 10 IP - 10 DP - 2020 Oct 10 TI - Rationale and design of a randomised controlled trial testing the effect of personalised diet in individuals with pre-diabetes or type 2 diabetes mellitus treated with metformin. PG - e037859 LID - 10.1136/bmjopen-2020-037859 [doi] LID - e037859 AB - INTRODUCTION: Metformin and diets aimed at promoting healthy body weight are the first line in treating type 2 diabetes mellitus (T2DM). Clinical practice, backed by clinical trials, suggests that many individuals do not reach glycaemic targets using this approach alone. The primary aim of the Personalised Medicine in Pre-diabetes-Towards Preventing Diabetes in Individuals at Risk (PREDICT) Study is to test the efficacy of personalised diet as adjuvant to metformin in improving glycaemic control in individuals with dysglycaemia. METHODS AND ANALYSIS: PREDICT is a two-arm, parallel group, single-masked randomised controlled trial in adults with pre-diabetes or early-stage T2DM (with glycated haemoglobin (HbA1c) up to 8.0% (64 mmol/mol)), not treated with glucose-lowering medication. PREDICT is conducted at the Clinical Research Facility at the Garvan Institute of Medical Research (Sydney). Enrolment of participants commenced in December 2018 and expected to complete in December 2021. Participants are commenced on metformin (Extended Release, titrated to a target dose of 1500 mg/day) and randomised with equal allocation to either (1) the Personalised Nutrition Project algorithm-based diet or (2) low-fat high-dietary fibre diet, designed to provide caloric restriction (75%) in individuals with body mass index >25 kg/m(2). Treatment duration is 6 months and participants visit the Clinical Research Facility five times over approximately 7 months. The primary outcome measure is HbA1c. The secondary outcomes are (1) time of interstitial glucose <7.8 mmol/L and (2) glycaemic variability (continuous glucose monitoring), (3) body weight, (4) fat mass and (5) abdominal visceral fat volume (dual-energy X-ray absorptiometry), serum (6) low-density lipoprotein cholesterol (7) high-density lipoprotein cholesterol and (8) triglycerides concentrations, (9) blood pressure, and (10) liver fat (Fibroscan). ETHICS AND DISSEMINATION: The study has been approved by the St Vincent's Hospital Human Research Ethics Committee (File 17/080, Sydney, Australia) and the Weizmann Institutional Review Board (File 528-3, Rehovot, Israel). The findings will be published in peer-reviewed open access medical journals. TRIAL REGISTRATION NUMBER: NCT03558867; Pre-results. CI - (c) Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. FAU - Htet, Thaw D AU - Htet TD AD - Healthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia. AD - St Vincent's Clinical School, UNSW, Sydney, New South Wales, Australia. AD - Department of Endocrinology, St Vincent's Hospital, Sydney, New South Wales, Australia. FAU - Godneva, Anastasia AU - Godneva A AD - Department of Computer Science & Applied Mathematics, Weizmann Institute of Science, Rehovot, Israel. FAU - Liu, Zhixin AU - Liu Z AD - Mark Wainwright Analytical Centre, UNSW, Sydney, New South Wales, Australia. FAU - Chalmers, Eliza AU - Chalmers E AD - Healthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia. FAU - Kolobkov, Dmitry AU - Kolobkov D AD - Department of Computer Science & Applied Mathematics, Weizmann Institute of Science, Rehovot, Israel. FAU - Snaith, Jennifer R AU - Snaith JR AD - Healthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia. AD - St Vincent's Clinical School, UNSW, Sydney, New South Wales, Australia. AD - Department of Endocrinology, St Vincent's Hospital, Sydney, New South Wales, Australia. FAU - Richens, Renee AU - Richens R AD - Healthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia. FAU - Toth, Krisztina AU - Toth K AD - Healthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia. FAU - Danta, Mark AU - Danta M AD - St Vincent's Clinical School, UNSW, Sydney, New South Wales, Australia. AD - Department of Gastroenterology, St Vincent's Hospital, Sydney, New South Wales, Australia. FAU - Hng, Tien-Ming AU - Hng TM AUID- ORCID: 0000-0001-6813-8813 AD - Diabetes and Endocrinology, Blacktown Mount Druitt Hospital, Sydney, New South Wales, Australia. AD - Blacktown Clinical School, Western Sydney University, Sydney, New South Wales, Australia. FAU - Elinav, Eran AU - Elinav E AUID- ORCID: 0000-0002-5775-2110 AD - Department of Immunology, Weizmann Institute of Science, Rehovot, Israel. FAU - Segal, Eran AU - Segal E AUID- ORCID: 0000-0002-6859-1164 AD - Department of Computer Science & Applied Mathematics, Weizmann Institute of Science, Rehovot, Israel. FAU - Greenfield, Jerry R AU - Greenfield JR AUID- ORCID: 0000-0002-0866-0973 AD - Healthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia. AD - St Vincent's Clinical School, UNSW, Sydney, New South Wales, Australia. AD - Department of Endocrinology, St Vincent's Hospital, Sydney, New South Wales, Australia. FAU - Samocha-Bonet, Dorit AU - Samocha-Bonet D AUID- ORCID: 0000-0001-9422-7852 AD - Healthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia d.samochabonet@garvan.org.au. AD - St Vincent's Clinical School, UNSW, Sydney, New South Wales, Australia. LA - eng SI - ClinicalTrials.gov/NCT03558867 PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20201010 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 RN - 0 (Blood Glucose) RN - 0 (Glycated Hemoglobin A) RN - 9100L32L2N (Metformin) SB - IM MH - Adult MH - Australia MH - Blood Glucose MH - Blood Glucose Self-Monitoring MH - *Diabetes Mellitus, Type 2/drug therapy MH - Diet MH - Glycated Hemoglobin/analysis MH - Humans MH - Israel MH - *Metformin/therapeutic use MH - *Prediabetic State/drug therapy PMC - PMC7552859 OTO - NOTNLM OT - diabetes & endocrinology OT - nutrition & dietetics COIS- Competing interests: EE and ES are paid consultants of the company DayTwo. MD has received travel support and speaker fees from Gilead, Abbvie and Merck. All other authors declare they have no conflict of interest. EDAT- 2020/10/12 06:00 MHDA- 2021/05/15 06:00 PMCR- 2020/10/10 CRDT- 2020/10/11 20:35 PHST- 2020/10/11 20:35 [entrez] PHST- 2020/10/12 06:00 [pubmed] PHST- 2021/05/15 06:00 [medline] PHST- 2020/10/10 00:00 [pmc-release] AID - bmjopen-2020-037859 [pii] AID - 10.1136/bmjopen-2020-037859 [doi] PST - epublish SO - BMJ Open. 2020 Oct 10;10(10):e037859. doi: 10.1136/bmjopen-2020-037859.