Insulin Resistance and Mild Cognitive Impairment (IRMCI) Study

Summary

Dementia (Alzheimer's Disease) is sometimes called "Type 3 Diabetes" because of the strong connection between Type 2 diabetes (a function of insulin resistance) with Dementia.

The investigators therefore hypothesize that Reducing Insulin Resistance using Intensive Lifestyle Intervention (Exercise and Weight loss) + Metformin Treatment in Prediabetic \& diet-control-only Diabetic overweight and mildly cognitively impaired individuals 55 years or older would lead to better Cognitive Function (compared to standard care) after 2 years.

Subjects will be monitored and assessed using a battery of Cognitive and psychological tests and PET scans to demonstrate glucose utilization in the relevant areas of the brain.

This 3-year open-label study aims to recruit 360 subjects with 50% (180 subjects) randomized to receiving Intensive lifestyle intervention with Metformin (if diabetic) vs the other 50% who would receive only the usual standard level of care in the primary care setting.

Conditions

• Mild Cognitive Impairment
• Insulin Resistance
• Diabetes 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.

Sponsors & Collaborators

• National University of Singapore

  collaborator OTHER

• Singapore General Hospital

  collaborator OTHER

• Changi General Hospital

  collaborator OTHER

• National University Hospital, Singapore

  collaborator OTHER

• Singapore Clinical Research Institute

  collaborator OTHER

• Agency for Science, Technology and Research

  collaborator OTHER

• Khoo Teck Puat Hospital

  collaborator OTHER

• Duke-NUS Graduate Medical School

  collaborator OTHER

• SingHealth Polyclinics

  lead OTHER

Principal Investigators

• NG TZE PIN, MD · National University of Singapore

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-03-11

Primary Completion

2019-12-31

Completion

2019-12-31

Countries

• Singapore

Study Locations