Using of Ice Cream for Diagnosis of Diabetes Mellitus

October 3, 2016 updated by: Chutintorn Sriphrapradang, Ramathibodi Hospital

Using of Ice Cream for Diagnosis of Diabetes Mellitus and Impaired Glucose Tolerance

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Faculty of Medicine Ramathibodi Hospital, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: oral glucose tolerance test
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
The 75-g glucose is used for standard oral glucose tolerance test.
Experimental: 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.
Other: ice cream
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The correct diagnosis of diabetes mellitus
Time Frame: 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.
2 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The correct diagnosis of impaired glucose tolerance
Time Frame: 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.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ramathibodi Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chutintorn Sriphrapradang, M.D., Ramathibodi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 08-55-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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