Personalised Medicine in Pre-diabetes and Early Type 2 Diabetes

• Status: Recruiting
• Trial end date: 2023-12-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Garvan Institute of Medical Research
• Collaborator: Weizmann Institute of Science
• Treatments: Metformin

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.

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.