Investigating Inter-individual Variability in Glycemic and Insulin Responses

Hyperglycemia Clinical Trial

Official title:

Investigating Inter-individual Variability in Glycemic and Insulin Responses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01804738
• Other study ID #: 2012/01149
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: June 2014

Study information

• Verified date: March 2019
• Source: Singapore Institute for Clinical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to test the following hypothesis in healthy lean young men:

• There are differences in glycemic response (GR) and insulin response (IR) between Chinese, Malay and Asian-Indian

• There are differences in GI values to the same food between ethnic groups

• There are ethnic differences postprandial GR and IR for high vs low GI foods

• Mastication, salivary amylase activity, gastric emptying rate and gut microbiota composition influences inter-individual glycemic and insulinemic variability

• Ethnic differences in mastication, salivary amylase activity, gastric emptying rate and gut microbiota composition determines the inter-ethnic glycemic and insulinemic variability

Description:

There is extensive evidence that numerous biological digestive factors varies between individuals and influence postprandial glycemic response (GR) and insulin response (IR), which are well established risk factors that precipitate the development of Type 2 diabetes mellitus (T2DM). However, no study to date has measured and compared physiological parameters such as mastication, salivary amylase activity, gastric emptying rates and gut microbiota in a multi-ethnic Asian population, with varying prevalence of obesity and T2DM. The aim of this study is to investigate ethnic differences in GR and IR as well as the GI values of foods. Additionally, we aim to examine how physiological digestive factors contribute to inter-ethnic and inter-individual variability in GR and IR. The study outcomes can potentially explain, in part, the varying susceptibility to obesity, T2DM and DM control between Chinese, Malays and Asian-Indians in Singapore, as reflected by the differences in prevalence of obesity, T2DM and DM control among the three local ethnic groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 40 Years

Eligibility

Inclusion Criteria:

• Be willing and able to comply with study procedures and given written informed consent

• Chinese/Malay/Indian males, aged 21-40 years old

• Body mass index (BMI) between 18.5 - 24.9 kg/m2

• Fasting blood glucose between 4 - 6 mmol/L

• Sedentary adults, with <1 episode of exercise per week

• Not have a history of food allergies or food intolerances

• Be a non-smoker

• Drinks less than 3 units of alcohol per day

• Not taking antibiotics for the past 3 weeks

Exclusion Criteria:

• Subjects with known chronic diseases, including diabetes, untreated hypertension, renal impairment, gastrointestinal problems, and other significant medical conditions

• BMI <18.5 kg/m2 or >25 kg/m2

• Fasting blood glucose =7.0mmol/l

• Alcohol consumption >3 drinks / day

• Use of medications known to affect glucose metabolism

• Recent changes in weight of >5% over the past 3 months

• Significant changes in diet over the past 3 months

• History of eating disorders or irregular eating habits

• Taking antibiotics medications over the past 3 weeks

Related Conditions & MeSH terms

• Hyperglycemia
• Insulin Resistance
• Insulin Sensitivity

Intervention

Other:
• Jasmine rice
Standardised rice:cooking liquid ratio for 50g available carbohydrate portion
• Parboiled basmati rice
Standardised rice:cooking liquid for 50g available carbohydrate portion

Locations

Country	Name	City	State
Singapore	Clinical Nutrition Research Centre	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore Institute for Clinical Sciences

Country where clinical trial is conducted

Singapore, 

References & Publications (3)

Ooi DS, Tan VM, Ong SG, Chan YH, Heng CK, Lee YS. Differences in AMY1 Gene Copy Numbers Derived from Blood, Buccal Cells and Saliva Using Quantitative and Droplet Digital PCR Methods: Flagging the Pitfall. PLoS One. 2017 Jan 26;12(1):e0170767. doi: 10.137 — View Citation

Tan VM, Ooi DS, Kapur J, Wu T, Chan YH, Henry CJ, Lee YS. The role of digestive factors in determining glycemic response in a multiethnic Asian population. Eur J Nutr. 2016 Jun;55(4):1573-81. doi: 10.1007/s00394-015-0976-0. Epub 2015 Jul 10. — View Citation

Tan VM, Wu T, Henry CJ, Lee YS. Glycaemic and insulin responses, glycaemic index and insulinaemic index values of rice between three Asian ethnic groups. Br J Nutr. 2015 Apr 28;113(8):1228-36. doi: 10.1017/S0007114515000586. Epub 2015 Mar 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Glycemic index values	Derivation of the glycemic index values of foods using postprandial glycemic response to reference food and test foods.	180 mins
Primary	Postprandial glycemic and insulin responses	Capillary bloods will be obtained using finger-pricks	Every 15 mins in the first hour and every 30 mins for the next 2 hours after food consumption
Secondary	Physiological digestive functions	They include: measurement of mastication rate, salivary amylase activity, gastric emptying rate and gut microbiota composition	Up to 5 hours