Personalised Medicine in Pre-diabetes and Early Type 2 Diabetes

Launched by GARVAN INSTITUTE OF MEDICAL RESEARCH · Jun 5, 2018

Keywords

ClinConnect Summary

Prediabetes is common in overweight and obese individuals and, as with frank diabetes, it is a risk factor for cardiovascular disease, cognitive dysfunction, fatty liver, kidney, ophthalmic, renal and neuropathic disease, and cancer.

Effective management of dysglycemia in pre-diabetes and diabetes and prevention of diabetes in individuals at risk reduce the risk of organ damage and associated co-morbidities and improves the affected individuals' quality of life.

Metformin, an oral biguanide, is the first-line treatment of newly-diagnosed type 2 diabetes patients, and the pharmacological c...

Gender

ALL

Eligibility 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.