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Clinical Trial Details

Trial ID: L4788
Source ID: NCT02409238
Associated Drug: Metformin
Title: Insulin Resistance and Mild Cognitive Impairment (IRMCI) Study
Acronym: IRMCI
Status: TERMINATED
Study Results: NO
Results:
Conditions: Mild Cognitive Impairment|Insulin Resistance|Diabetes Mellitus, Type 2
Interventions: DRUG: Metformin|BEHAVIORAL: Intensive Lifestyle Intervention|BEHAVIORAL: Standard LIfestyle Recommendation
Outcome Measures: Primary: Primary efficacy endpoint (Cerebral Glucose Metabolic Rate), Change in Cerebral glucose metabolic rate \& MRI Measures of Cerebral Volumetric and functional changes and white matter structural and functional connectivity as measured by Fluorodeoxyglucose Positron Emission Tomography \& 3T MRI (FDG-PET/MRI) scans at Baseline and at 2 years., 2 years|Primary cognitive endpoint (Neuropsychological Performance), Change in Composite z-score of memory and multi-domain non-amnestic cognitive test performance using a Neuropsychological Assessment performed at Baseline and at 2 years., 2 years | Secondary: Secondary clinical endpoints Subjective Memory and Cognitive Complaint (SMCC, Change in Subjective Memory and Cognitive Complaint (SMCC) as measured at baseline and at 2 years., 2 years|Secondary clinical endpoints Basic Activities of Daily Liver (ADL), Change in Basic Activities of Daily Liver (ADL) as measured at baseline and at 2 years., 2 years|Secondary clinical endpoints Cognitive Instrumental Activities of Daily Living Scale, Change in Cognitive Instrumental Activities of Daily Living Scale (Cog-IADL) as measured at baseline and at 2 years., 2 years|Secondary clinical endpoints Global Clinical Dementia Rating Sum of Boxes, Change in Global Clinical Dementia Rating Sum of Boxes (version with Informant and version without need for Informant- CDR-SB) as measured at baseline and at 2 years., 2 years|Secondary clinical endpoints Mini-Mental State Examination, Change in Mini-Mental State Examination \[MMSE\]as measured at baseline and at 2 years., 2 years|Secondary clinical endpoints Montreal Cognitive Assessment scale, Change in Montreal Cognitive Assessment scale \[MoCA\] as measured at baseline and at 2 years., 2 years|Secondary adherence endpoints fasting plasma insulin, Markers of lowered insulin resistance (Change in fasting plasma insulin) as measured at baseline and at 2 years., 2 years|Secondary adherence endpoints Homeostatic Model Assessment (HOMA), Markers of lowered insulin resistance \[Change in Homeostatic Model Assessment (HOMA)\] as measured at baseline and at 2 years., 2 years|Secondary adherence endpoints Lifestyle Intervention (Change in Weight), Lifestyle Intervention (Change in Weight) as measured at baseline and at 2 years., 2 years|Secondary adherence endpoints Body Mass Index, Lifestyle Intervention \[Change in Body Mass Index (BMI)\] as measured at baseline and at 2 years., 2 years|Secondary adherence endpoints Waist Circumference, Lifestyle Intervention (Change in Waist Circumference) as measured at baseline and at 2 years., 2 years|Secondary adherence endpoints Fasting plasma glucose, Glycemic Control (Change in Fasting plasma glucose) as measured at baseline and at 2 years., 2 years|Secondary adherence endpoints Glycated Hemoglobin (HbA1c), Glycemic Control \[Change in Glycated Hemoglobin (HbA1c)\] as measured at baseline and at 2 years., 2 years|Secondary adherence endpoints Fasting Lipids, Metabolic control \[Change in Fasting Lipids (total cholesterol, HDL-Chol, LDL-Chol, triglycerides)\] as measured at baseline and at 2 years., 2 years
Sponsor/Collaborators: Sponsor: SingHealth Polyclinics | Collaborators: National University of Singapore|Singapore General Hospital|Changi General Hospital|National University Hospital, Singapore|Singapore Clinical Research Institute|Agency for Science, Technology and Research|Khoo Teck Puat Hospital|Duke-NUS Graduate Medical School
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 105
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-03-11
Completion Date: 2019-12-31
Results First Posted:
Last Update Posted: 2023-01-11
Locations: SingHealth Polyclinics - Marine Parade Polyclinic, Singapore, 440080, Singapore
URL: https://clinicaltrials.gov/show/NCT02409238