Personalised Medicine in Pre-diabetes and Early Type 2 Diabetes
PREDICT
Personalised Medicine in Prediabetes - Towards Preventing Diabetes in Individuals At Risk
1 other identifier
interventional
138
1 country
1
Brief Summary
Prediabetes is a common condition in overweight individuals affecting approximately 35% of American adults and 30% of Australian adults. Like diabetes, prediabetes is a serious risk factor for cardiovascular disease, eye, kidney and liver disease, and some types of cancer. Appropriate blood glucose control is crucial in preventing pre-diabetes complications and onset of diabetes, yet clinical practice, backed by randomised trials, reports that many patients treated with standard dietary guidelines or with the first-line treatment of diabetes patients, metformin, do not improve blood glucose control sufficiently. The overarching goal of the present project is to improve the efficacy of metformin mono-therapy in pre-diabetes and early type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2018
CompletedStudy Start
First participant enrolled
June 5, 2018
CompletedFirst Posted
Study publicly available on registry
June 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 23, 2024
CompletedOctober 31, 2024
August 1, 2023
5.5 years
June 5, 2018
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change in glycated haemoglobin (HbA1C, %) from baseline
Difference in the reduction of HbA1C between the groups
6 months
Secondary Outcomes (10)
Total daily time of interstitial glucose levels below 7.8 mmol/L (140 mg/dL)
6 months
Glycaemic variability
6 months
Body weight
6 months
Body fat mass
6 months
Abdominal visceral fat volume
6 months
- +5 more secondary outcomes
Other Outcomes (1)
Gut microbiome (exploratory)
6 months
Study Arms (2)
Metformin + Healthy diet
PLACEBO COMPARATORMetformin (1500 mg/d, Extended Release) + Healthy, low fat diet
Metformin + Personalized diet
ACTIVE COMPARATORMetformin (1500 mg/d, Extended Release) + Personalized diet based on an algorithm developed at the Weizmann Institute of Science (Zeevi et al, Cell 2015)
Interventions
Metformin (1500 mg/d, Extended Release) + Healthy, low fat diet
Metformin (1500 mg/d, Extended Release) + Algorithm-based personalized diet
Eligibility Criteria
You may qualify if:
- Individuals with pre-diabetes or newly-diagnosed (in the last 6 months) with type 2 diabetes, fulfilling the following criteria:
- Impaired fasting glucose (IFG, plasma glucose \[PG\]- 5.6 - 6.9 mmol/L, ±0.2 mmol/L) and/or impaired glucose tolerance (IGT, 2-h PG 7.8 - 11.0 mmol/L, ±0.2 mmol/L) with or without elevated HbA1c (up to 8.0 %).
- Willingness to provide written informed consent and willingness to participate and comply with the study.
You may not qualify if:
- Females planning a pregnancy during the course of the research or 3 months after completion of the research project.
- Patients with type 1 diabetes, chronically active inflammatory disease, neoplastic disease in the previous 3 years, chronic gastrointestinal disorders, including inflammatory bowel disease or celiac.
- Liver enzymes ALT and/or AST\>3-times normal range limit.
- Abnormal renal function as measured by (eGFR\<45 mL/min/1.73m\^2).
- Individuals with a history of a psychological illness or condition that may interfere with the individual's ability to understand the requirements of the study.
- Normo-glycaemia.
- HbA1c\>8.0%
- Cardiovascular event in the previous 6 months.
- Current or recent (within 24 months) treatment with a glucose lowering medication (i.e. GLP-1 receptor agonist, SGLT2 inhibitor, thiazolidinedione, sulfonylurea, DPP-4 inhibitor or insulin).
- Current or recent (within 3 months) treatment with metformin.
- Treatment with an oral steroid.
- Treatment with antibiotics/antifungal in the last 3 month.
- Treatment with immunosuppressive medications.
- Alcohol or substance abuse.
- Participants who had received an investigational new drug within the last 6 months.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Garvan Institute of Medical Research
Sydney, New South Wales, 2010, Australia
Related Publications (1)
Htet TD, Godneva A, Liu Z, Chalmers E, Kolobkov D, Snaith JR, Richens R, Toth K, Danta M, Hng TM, Elinav E, Segal E, Greenfield JR, Samocha-Bonet D. 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. BMJ Open. 2020 Oct 10;10(10):e037859. doi: 10.1136/bmjopen-2020-037859.
PMID: 33040003DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dorit Samocha-Bonet, PhD
Garvan Institute of Medical Research
- PRINCIPAL INVESTIGATOR
Jerry Greenfield, MD, PhD
Garvan Institute of Medical Research
- PRINCIPAL INVESTIGATOR
Eran Elinav, MD, PhD
Weizmann Institute of Science
- PRINCIPAL INVESTIGATOR
Eran Segal, PhD
Weizmann Institute of Science
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2018
First Posted
June 15, 2018
Study Start
June 5, 2018
Primary Completion
December 15, 2023
Study Completion
July 23, 2024
Last Updated
October 31, 2024
Record last verified: 2023-08