TY - JOUR
T1 - 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
AU - Htet, Thaw D.
AU - Godneva, Anastasia
AU - Liu, Zhixin
AU - Chalmers, Eliza
AU - Kolobkov, Dmitry
AU - Snaith, Jennifer R.
AU - Richens, Renee
AU - Toth, Krisztina
AU - Danta, Mark
AU - Hng, Tien Ming
AU - Elinav, Eran
AU - Segal, Eran
AU - Greenfield, Jerry R.
AU - Samocha-Bonet, Dorit
N1 - Funding This work is supported by the Garvan Research Foundation and the St Vincent’s Clinic Foundation, Sydney, Australia. The study sponsor is the Garvan Institute of Medical Research, 384 Victoria Street, Darlinghurst, NSW 2020, Australia, +61 2 92958100. Contributors DS-B, JRG, ES and EE contributed to the conception and design of the study. TDH, AG and DS-B drafted the manuscript. AG and ZL contributed to the study design and the statistical plan. ZL contributed to the sample size estimation. AG, DK, RR, KT, EC, MD, JRS and T-MH contributed to the collection of the data. All authors revised and approved the final version of the manuscript and agree to be accountable for all aspects of the work.
PY - 2020/10/10
Y1 - 2020/10/10
N2 - 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.
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.
UR - http://www.scopus.com/inward/record.url?scp=85092752637&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2020-037859
DO - 10.1136/bmjopen-2020-037859
M3 - مقالة
C2 - 33040003
SN - 2044-6055
VL - 10
JO - BMJ Open
JF - BMJ Open
IS - 10
M1 - e037859
ER -