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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03558867




Registration number
NCT03558867
Ethics application status
Date submitted
5/06/2018
Date registered
15/06/2018
Date last updated
31/10/2024

Titles & IDs
Public title
Personalised Medicine in Pre-diabetes and Early Type 2 Diabetes
Scientific title
Personalised Medicine in Prediabetes - Towards Preventing Diabetes in Individuals At Risk
Secondary ID [1] 0 0
SVH 17/080
Universal Trial Number (UTN)
Trial acronym
PREDICT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre Diabetes 0 0
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Metformin + Healthy diet
Treatment: Drugs - Metformin + Personalized diet

Placebo comparator: Metformin + Healthy diet - Metformin (1500 mg/d, Extended Release) + Healthy, low fat diet

Active comparator: Metformin + Personalized diet - Metformin (1500 mg/d, Extended Release) + Personalized diet based on an algorithm developed at the Weizmann Institute of Science (Zeevi et al, Cell 2015)


Treatment: Drugs: Metformin + Healthy diet
Metformin (1500 mg/d, Extended Release) + Healthy, low fat diet

Treatment: Drugs: Metformin + Personalized diet
Metformin (1500 mg/d, Extended Release) + Algorithm-based personalized diet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean change in glycated haemoglobin (HbA1C, %) from baseline
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Total daily time of interstitial glucose levels below 7.8 mmol/L (140 mg/dL)
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Glycaemic variability
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Body weight
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Body fat mass
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
Abdominal visceral fat volume
Timepoint [5] 0 0
6 months
Secondary outcome [6] 0 0
Serum low-density lipoprotein (LDL)-cholesterol concentration
Timepoint [6] 0 0
6 months
Secondary outcome [7] 0 0
Serum high-density lipoprotein (HDL)-cholesterol concentration
Timepoint [7] 0 0
6 months
Secondary outcome [8] 0 0
Serum triglycerides concentration
Timepoint [8] 0 0
6 months
Secondary outcome [9] 0 0
Blood pressure
Timepoint [9] 0 0
6 months
Secondary outcome [10] 0 0
Liver fat
Timepoint [10] 0 0
6 months

Eligibility
Key inclusion criteria
Inclusion criteria:

* 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.
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.
* Participants involved in another clinical study.
* Participants who actively lose weight.
* Participants who had a bariatric surgery.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/07/2024
Sample size
Target
Accrual to date
Final
138
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Garvan Institute of Medical Research - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Garvan Institute of Medical Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Weizmann Institute of Science
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT03558867
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Dorit Samocha-Bonet, PhD
Address 0 0
Garvan Institute of Medical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03558867