Logo 1 Logo 2

Clinical Trial Details

Trial ID: L3581
Source ID: NCT03558867
Associated Drug: Metformin + Healthy Diet
Title: Personalised Medicine in Pre-diabetes and Early Type 2 Diabetes
Acronym: PREDICT
Status: COMPLETED
Study Results: NO
Results:
Conditions: Pre Diabetes|Type 2 Diabetes Mellitus
Interventions: DRUG: Metformin + Healthy diet|DRUG: Metformin + Personalized diet
Outcome Measures: Primary: Mean change in glycated haemoglobin (HbA1C, %) from baseline, Difference in the reduction of HbA1C between the groups, 6 months | Secondary: Total daily time of interstitial glucose levels below 7.8 mmol/L (140 mg/dL), Difference in the time (minutes) per day with interstitial glucose measured below 7.8 mmol/L (140 mg/dL) between the groups, 6 months|Glycaemic variability, Difference in the glycaemic variability as derived from CGM between the groups, 6 months|Body weight, Difference in the magnitude of weight loss between the groups, 6 months|Body fat mass, Difference in body fat mass composition as assessed using dual-energy X-ray absorptiometry (DXA) between the groups, 6 months|Abdominal visceral fat volume, Difference in the abdominal visceral fat volume as assessed using DXA between the groups, 6 months|Serum low-density lipoprotein (LDL)-cholesterol concentration, Difference in serum LDL-cholesterol between the groups, 6 months|Serum high-density lipoprotein (HDL)-cholesterol concentration, Difference in serum HDL-cholesterol concentration between the groups, 6 months|Serum triglycerides concentration, Difference in serum triglycerides between the groups, 6 months|Blood pressure, Difference in diastolic and systolic blood pressure between the groups, 6 months|Liver fat, Difference in liver fat measured by the Fibroscan's controlled attenuation parameter (CAP) function between the groups, 6 months | Other: Gut microbiome (exploratory), Difference in gut microbiome features between the groups, 6 months
Sponsor/Collaborators: Sponsor: Garvan Institute of Medical Research | Collaborators: Weizmann Institute of Science
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 138
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2018-06-05
Completion Date: 2024-07-23
Results First Posted:
Last Update Posted: 2024-10-31
Locations: Garvan Institute of Medical Research, Sydney, New South Wales, 2010, Australia
URL: https://clinicaltrials.gov/show/NCT03558867