Using of Ice Cream for Diagnosis of Diabetes Mellitus

NCT02854111 | Completed

• 1 other identifier: 08-55-03
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• The correct diagnosis of diabetes mellitus

  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.

  2 hours

Secondary Outcomes (1)

• The correct diagnosis of impaired glucose tolerance

  2 hours

Study Arms (2)

oral glucose tolerance test

ACTIVE COMPARATOR

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.

Other: 75 g-glucose

ice cream

EXPERIMENTAL

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.

Other: ice cream

Interventions

ice cream OTHER

The ice cream was made by nutritionists in Ramathibodi Hospital. It consisted of cornstarch, milk, sucrose, milk powder, egg yolk, and banana which contained carbohydrate 73.9 g, fat 27.7 g, protein 18.9 g for a total of 620.9 kcal with a cost of 35 bahts. The time for complete ingesting 75-g glucose and ice cream was 5 and 15 minutes, respectively.

ice cream

75 g-glucose OTHER

The 75-g glucose is used for standard oral glucose tolerance test.

oral glucose tolerance test

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy volunteer
• agree to participate by written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramathibodi Hospital: lead

Study Sites (1)

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Bangkok, 10400, Thailand

Location

Related Publications (1)

• Chanprasertpinyo W, Bhirommuang N, Surawattanawiset T, Tangsermwong T, Phanachet P, Sriphrapradang C. Using Ice Cream for Diagnosis of Diabetes Mellitus and Impaired Glucose Tolerance: An Alternative to the Oral Glucose Tolerance Test. Am J Med Sci. 2017 Dec;354(6):581-585. doi: 10.1016/j.amjms.2017.08.007. Epub 2017 Aug 18.

  PMID: 29208255 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Ice Cream; Glucose

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Chutintorn Sriphrapradang, M.D.

  Ramathibodi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 3, 2016
• Study Start: July 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 4, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)