Evidence map›Paper›PMID 33040003›Full record

ArticleBMJ open2020

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.

Thaw D Htet, Anastasia Godneva, Zhixin Liu, Eliza Chalmers, Dmitry Kolobkov, Jennifer R Snaith, Renee Richens, Krisztina Toth, Mark Danta, Tien-Ming Hng and 4 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT03558867. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.1field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03558867 nacompleted

Personalised Medicine in Prediabetes - Towards Preventing Diabetes in Individuals At Risk

Ran2018Enrolled138Registered outcomes12Posted comparisons0ConditionsPre Diabetes, Type 2 Diabetes MellitusArmsMetformin + Healthy diet, Metformin + Personalized diet
Open the trial in the graph
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Article
  6. Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 4 institutions in 2 countries.

Thaw D Htet *Healthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia.
Anastasia Godneva *Department of Computer Science & Applied Mathematics, Weizmann Institute of Science, Rehovot, Israel.
Zhixin LiuMark Wainwright Analytical Centre, UNSW, Sydney, New South Wales, Australia.
Eliza ChalmersHealthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia.
Dmitry KolobkovDepartment of Computer Science & Applied Mathematics, Weizmann Institute of Science, Rehovot, Israel.
Jennifer R SnaithHealthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia.
Renee RichensHealthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia.
Krisztina TothHealthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia.
Mark DantaSt Vincent's Clinical School, UNSW, Sydney, New South Wales, Australia.
Tien-Ming HngDiabetes and Endocrinology, Blacktown Mount Druitt Hospital, Sydney, New South Wales, Australia.ORCID 0000-0001-6813-8813
Eran ElinavDepartment of Immunology, Weizmann Institute of Science, Rehovot, Israel.ORCID 0000-0002-5775-2110
Eran SegalDepartment of Computer Science & Applied Mathematics, Weizmann Institute of Science, Rehovot, Israel.ORCID 0000-0002-6859-1164
Jerry R GreenfieldHealthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia.ORCID 0000-0002-0866-0973
Dorit Samocha-BonetHealthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia d.samochabonet@garvan.org.au.ORCID 0000-0001-9422-7852
Garvan Institute of Medical Research · AUWeizmann Institute of Science · ILUNSW Sydney · AUBlacktown & Mount Druitt Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMetformin 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 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.

Indexed as

Diabetes Mellitus, Type 2MetforminPrediabetic StateAdultAustraliaBlood GlucoseBlood Glucose Self-MonitoringDietGlycated HemoglobinHumansIsraelRandomized Controlled Trials as TopicBlood GlucoseGlycated HemoglobinMetformindiabetes & endocrinologynutrition & dietetics

Identifiers

PMID33040003
PMCPMC7552859
OpenAlexW3091971671

What OpenQuestion holds

Texttitle and abstract
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.