Asian Indian Prediabetes Study

NCT04507685 | Completed DMC

• 1 other identifier: 2019-078
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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 insulin sensitivity and improving pancreatic function in Indians to prevent diabetes and lower the risk of heart disease. A low carbohydrate diet can deplete fat from undesirable places, such as fat around organs in the abdominal cavity. In this study, we will determine if restriction of dietary carbohydrates will deplete fat in the pancreas and liver, and improve insulin sensitivity and early insulin secretion in Indians. These changes may prevent diabetes from developing. Hepatic and pancreatic fat will be measured using magnetic resonance imaging. Insulin sensitivity and secretion will be measured during an oral glucose tolerance test. In addition, this study will investigate if the higher insulin resistance in Indians is due to genes that cause the inability to store fat in the legs. The results on the type of diet that is more effective for reducing pancreatic and hepatic fat is important for informing dietary guidelines on the use of low carbohydrate diets for diabetes prevention, particularly in Indians who have a higher risk of developing diabetes.

Conditions

Pre Diabetes

Keywords

Asian Indians; Prediabetes; Insulin Resistance; Low glycaemic diet; Ectopic Fat

Outcome Measures

Primary Outcomes (5)

• Change in β-cell Function [First-phase β-cell response (PhiD)]

  First-phase β-cell response (PhiD) will be calculated from blood glucose and C-peptide data during a 3h 75g oral glucose tolerance test (OGTT) using the C-peptide minimal model.

  Week 0, 8 and 24

• Change in Insulinogenic index (ΔC-peptide/∆glucose during the first 30 minutes of the OGTT)

  ΔC-peptide/∆glucose during the first 30 minutes of the OGTT will be calculated as an index of early insulin secretion (Insulinogenic index).

  Week 0, 8 and 24

• Change in Incremental AUC

  Incremental AUC over 180 minutes of the OGTT will be calculated for glucose, insulin, and C-peptide.

  Week 0, 8 and 24

• Change in Insulin sensitivity (Oral Minimal model)

  Insulin sensitivity will be calculated from blood glucose, insulin and C-peptide during a 3h 75g oral glucose tolerance test (OGTT) using both the oral minimal model

  Week 0, 8 and 24

• Change in Matsuda index for whole body insulin sensitivity

  Week 0, 8 and 24

Secondary Outcomes (14)

• Change in Body fat distribution

  Week 0, 8 and 24

• Change in Weight (kg)

  Week 0, 8 and 24

• Change in Blood Pressure

  Week 0, 8 and 24

• Change in Body Composition- Total body fat

  Week 0, 8 and 24

• Change in Body Composition- Total lean mass

  Week 0, 8 and 24

Other Outcomes (6)

• Change in respiratory quotient (RQ)

  Week 0, 8 and 24

• Change in blood ketone (β-hydroxybutyrate, βHB) concentrations

  Week 0, 8 and 24

• Change in 24-h urinary urea to creatinine ratio

  Week 0, 8 and 24

Study Arms (2)

Low Glycaemic Diet (LG)

EXPERIMENTAL

Low carbohydrate, low saturated fat diet

Other: Lifestyle (Diet and Exercise)

Control Diet

ACTIVE COMPARATOR

High unrefined carbohydrate, low fat diet

Other: Lifestyle (Diet and Exercise)

Interventions

Lifestyle (Diet and Exercise) OTHER

The LG diet will comprise 20% carbohydrate, 30% protein, and 50% fat (\<10% saturated fat). It will have a low glycaemic load; include plant and animal protein; non-starchy vegetables and salad greens; and some low-sugar fruit. Participants will be encouraged to incorporate a variety of foods rich in monounsaturated and polyunsaturated fats in their diet. The control diet will comprise 50% carbohydrate, 20% protein and 30% total fat (\<10% saturated fat). It will reflect the Health Promotion Board's (HPB) recommendations to reduce dietary fat, emphasize wholegrains and include a variety of fruits and vegetables. In contrast to the LG diet, the control diet will have a higher glycaemic load with a greater proportion of energy derived from unrefined carbohydrate foods. Concurrent to the dietary intervention and consistent with physical activity guidelines, all participants will undertake a 60-min structured exercise program incorporating aerobic/ resistance exercises 3-4 days/week.

Control Diet; Low Glycaemic Diet (LG)

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute for Human Development and Potential (IHDP), Singapore: lead
• National Medical Research Foundation (NMRC) Singapore: collaborator
• Almond Board of California: collaborator

Study Sites (1)

Singapore Institute for Clinical Sciences (SICS)

Singapore, 117549, Singapore

Location

MeSH Terms

Conditions

Glucose Intolerance; Prediabetic State; Insulin Resistance

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jeannie Tay, PhD

  Institute for Human Development and Potential (IHDP), Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Model Details: 24-week parallel arm, randomized controlled trial (RCT)

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 11, 2020
• Study Start: October 19, 2020
• Primary Completion: January 27, 2023
• Study Completion: February 1, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

SG (1)