Insulin Resistance and Mild Cognitive Impairment (IRMCI) Study

PHASE4TerminatedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

March 11, 2015

Primary Completion Date

December 31, 2019

Study Completion Date

December 31, 2019

Conditions
Mild Cognitive ImpairmentInsulin ResistanceDiabetes Mellitus, Type 2
Interventions
DRUG

Metformin

Metformin dosage schedule: 250 mg thrice a day titrated from 250 mg once a day. Patients will first be started on Metformin 250 mg once a day with meals, and the dose increased to 250 mg twice a day at Day 8, to 250 mg three times a day at Day 15, subject to reports of poor tolerance of gastrointestinal symptoms or other side effects.

BEHAVIORAL

Intensive Lifestyle Intervention

"The intensive lifestyle interventions for the Active Intervention groups will be done at the Lifestyle Intervention Centres. The aim would to achieve and maintain a weight reduction of at least 7 percent of initial body weight through a healthy reduced-calorie, low-fat diet and engagement in physical activity of moderate intensity for at least 150 minutes per week.~This will be accomplished through a programme of individualized fitness assessment and exercise prescription for cardiovascular, strength and functional training that is standardized across study sites and facilities. The programme comprises an initial 32 sessions (2 times weekly) for supervised gym workout over 16 weeks, followed by maintenance programme of regular unsupervised exercises."

BEHAVIORAL

Standard LIfestyle Recommendation

The standard lifestyle recommendations for the Control groups are in the form of standard diabetic education pamphlets and a 20-to-30-minute individual session that emphasizes the importance of a healthy lifestyle to reduce their weight and to increase their physical activity. Activity will be monitored using a pedometer.

Trial Locations (1)

440080

SingHealth Polyclinics - Marine Parade Polyclinic, Singapore

All Listed Sponsors
collaborator

National University of Singapore

OTHER

collaborator

Singapore General Hospital

OTHER

collaborator

Changi General Hospital

OTHER

collaborator

National University Hospital, Singapore

OTHER

collaborator

Singapore Clinical Research Institute

OTHER

collaborator

Agency for Science, Technology and Research

OTHER

collaborator

Khoo Teck Puat Hospital

OTHER

collaborator

Duke-NUS Graduate Medical School

OTHER

lead

SingHealth Polyclinics

OTHER