Using of Ice Cream for Diagnosis of Diabetes Mellitus

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Other: 75 g-glucose; Other: ice cream

• Registration Number: NCT02854111
• Lead Sponsor: Ramathibodi Hospital

Brief Summary

The overall global prevalence of type 2 diabetes mellitus (DM) is rising. Based on the latest Thai National Health Examination Survey, an estimated 3.2 million people had DM, of whom one-third was undiagnosed. The inexpensive oral glucose tolerance test (OGTT) is a more sensitive and reliable test of DM than fasting plasma glucose (FPG) or HbA1c, and is recommended for diagnosing DM and impaired glucose tolerance (IGT). Although the OGTT provides useful diagnostic information, poor patient tolerance of glucose solutions is inevitable.

Detailed Description

Regarding the diagnosis of DM, oral glucose tolerance test (OGTT) identifies about 2% more individuals than does fasting plasma glucose (FPG). Hence OGTT is the method that has high sensitivity compared to other methods for diagnosis of IGT (impaired glucose tolerance) and diabetes. However, standard OGTT with 75-g glucose has poor patient tolerance and might cause reactive hypoglycemia. The alternatives for 75-g glucose would help for screening of DM with better tolerance. There were previous studies investigated substitutes for oral glucose solution with cookies and muffin. In the present study we hypothesized that an alternative food such as ice cream, a favorite dessert, can use for evaluation of the diagnosis of DM and IGT instead of standard 75-g glucose.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2016-07-28
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-03
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-03
• Last Update Posted: 2016-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• healthy volunteer
• agree to participate by written informed consent

Exclusion Criteria

• previous history of diabetes mellitus
• pregnant woman
• hospitalised patients
• underlying disease of liver and kidney disease
• who take any medications that interfere with plasma glucose levels such as steroid

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
oral glucose tolerance test	75 g-glucose	75-g glucose A blood sample will be collected when the participants arrive. This is a fasting blood glucose value. Then the participants will be asked to drink a sweet liquid containing 75 g-glucose. Blood samples will be collected at timed intervals of 1 and 2 hours after you drink the glucose. This is a standard method for diagnosis of diabetes mellitus that called oral glucose tolerance test or OGTT.
ice cream	ice cream	A blood sample will be collected when the participants arrive. This is a fasting blood glucose value. Then the participants will be asked to drink ice cream that contained carbohydrate 73.9 g. Blood samples will be collected at timed intervals of 1 and 2 hours after you eat the ice cream.

Primary Outcome Measures

Name	Time	Method
The correct diagnosis of diabetes mellitus	2 hours	We calculate the percentage of wrong diagnosis of diabetes mellitus when using ice cream instead of 75-g glucose (gold standard test). We also calculate sensitivity and specificity of ice cream test for diagnosis of diabetes mellitus.

Secondary Outcome Measures

Name	Time	Method
The correct diagnosis of impaired glucose tolerance	2 hours	We calculate the percentage of wrong diagnosis of impaired glucose tolerance using ice cream instead of 75-g glucose (gold standard test). We also calculate sensitivity and specificity of ice cream test for diagnosis of impaired glucose tolerance.

Trial Locations

Locations (1)

Faculty of Medicine Ramathibodi Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand