Status:
COMPLETED
Asian Indian Prediabetes Study
Lead Sponsor:
Institute for Human Development and Potential (IHDP), Singapore
Collaborating Sponsors:
National Medical Research Foundation (NMRC) Singapore
Almond Board of California
Conditions:
Pre Diabetes
Eligibility:
All Genders
21-50 years
Phase:
NA
Brief Summary
Compared to other races, Indians have higher insulin resistance, poorer pancreatic function and a greater risk of developing diabetes, highlighting the importance of early strategies for improving ins...
Detailed Description
Compared to other races, Indians have a greater risk of developing type 2 diabetes (T2D), increased insulin resistance (IR) and more rapid decline in β-cell function, highlighting the urgency and impo...
Eligibility Criteria
Inclusion
- Male or female
- Asian Indian ethnicity
- Age between 21-50 years
- BMI not greater than 35 or less than 25
- Prediabetes (based on results from an OGTT conducted in the last 3 months):
- Impaired Fasting Glucose (IFG) which is a fasting blood glucose level of between 5.6 to 6.9 mmol/l and/or
- Impaired Glucose Tolerance (IGT) which is a blood glucose level of 7.8 to 11.0 mmol/l, 2 hours after the OGTT but below 7.0 mmol/l in the fasting state.
- Not have type 1 or type 2 diabetes
- Not on any diabetes medications that affect insulin sensitivity e.g. metformin, glitazones
- No abnormality of clinical significance on medical history
- If female, not pregnant or breast feeding
- No history of coronary artery disease or cardiac (heart) abnormalities
- Participants must understand the procedures involved and agree to participate in the study by giving full informed, written consent
Exclusion
- BMI greater than 35 or less than 25
- Weight gain or loss of more than 5% over the past 3 months
- Have anaemia (low haemoglobin/ red blood cell levels), a malignancy (cancer), abnormal liver function, any significant endocrinopathy (e.g. thyroid problems), or a history of metabolic disease such as liver, kidney, cardiovascular, respiratory or gastrointestinal disease.
- Have high uncontrolled hypertension (resting seated blood pressure \>160/100 mmHg)
- Taking medications that may affect glucose metabolism e.g. steroids, thiazide diuretics at doses\>25mg/day.
- History of smoking or using nicotine products during the 6 months prior to study
- History of heavy alcohol consumption (\> 5 standard drinks/day)
- Inability to limit alcohol consumption for study duration
- Lactose Intolerant or have a nut allergy
- Have depression
- Have a musculoskeletal injury, joint or peripheral vascular disease sufficient to impede exercise (such as hip arthritis, foot, ankle problems or pain)
- Have severe exercise-induced asthma
- Participating in a regular aerobic or resistance exercise program
- Currently on a weight reducing diet or have an eating disorder
- Contraindications for MRI e.g. if you have certain metallic implants/devices such as heart valves of a cardiac pacemaker which may be affected by the magnetic field
- Unwilling to be randomized to either diet group
- Extended absences due to travel or other commitments
- Unable to comprehend or cope with study requirements
Key Trial Info
Start Date :
October 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04507685
Start Date
October 19 2020
End Date
February 1 2023
Last Update
November 22 2023
Active Locations (1)
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1
Singapore Institute for Clinical Sciences (SICS)
Singapore, Singapore, 117549