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COMPLETED

NCT03558867

Personalised Medicine in Pre-diabetes and Early Type 2 Diabetes

Sponsor: Garvan Institute of Medical Research

View on ClinicalTrials.gov

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.

Official title: Personalised Medicine in Prediabetes - Towards Preventing Diabetes in Individuals at Risk

Key Details

Gender

All

Age Range

20 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

138

Start Date

2018-06-05

Completion Date

2024-07-23

Last Updated

2026-10-05

Healthy Volunteers

Conditions

Pre Diabetes Type 2 Diabetes Mellitus

Interventions

DRUG

Metformin + Healthy diet

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

DRUG

Metformin + Personalized diet

Metformin (1500 mg/d, Extended Release) + Algorithm-based personalized diet

Inclusion criteria: * Prediabetes or early-stage type 2 diabetes according to the American Diabetes Association (2019) diagnostic criteria, with HbA1c ≤8.0% (64 mmol/mol). * Women of childbearing potential willing to take precautions to avoid pregnancy throughout the study and for 3 months after the end of treatment. * Willingness to provide written informed consent and willingness to participate and comply with the study. Exclusion Criteria: * Females planning a pregnancy during the course of the research or 3 months after completion of the research project. Females who breastfeed. * 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 in the last 3 months. * Treatment with immunosuppressive medications. * Treatment with medications known to interact with metformin, including cimetidine, vitamin K antagonists and nifedipine. * 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. * Any reason the Investigator believes the participant is not likely to be adherent to the study treatment and protocol, including non-adherence to run-in.

Locations (1)

Garvan Institute of Medical Research

Sydney, New South Wales, Australia