A Comparison of European and Chinese Blood Sugar Responses | NCT02577874

Studies
A Comparison of European and Chinese Blood Sugar Responses

NCT02577874

Sponsor

Small Changes

Status

Unknown status

Last Update Posted

Oct 16, 2015Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Diabetes

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Nov 2015Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

Jun 15, 2015

First Submission Date that Met QC Criteria

Oct 15, 2015

First Posted Date

Oct 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2015

Last Update Posted Date

Oct 16, 2015Estimated

Name	Class
Sheffield Hallam University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is designed to compare the responses to an oral glucose challenge between people of European and Chinese heritage (essential participants in the European arm must have tow European parents and likewise for the Chinese participants).

Detailed Description

100 participants (50 European and 50 Chinese) will attend a lab after an overnight fast and have a capillary finger-prick blood test to assess fasted blood glucose levels and then consume a 50 gram glucose solution. Blood test will be repeated at 15, 30, 45, 60, 90 and 120 minutes post consumption of the glucose solution. This test will be repeated on a spate occasion at least a week later than the first test. Participants will only take part in the experiment after singing informed consent and agreeing to take part in the study and after a medical screening questionnaire assessing that they are non-diabetic or haemophiliac or have blood born infections.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chinese Subjects		7 blood glucose tests taken over a two hour period
European Subjects		7 blood glucose tests taken over a two hour period

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood sugar response measured by 7 finger prick blood samples	7 finger prick blood samples	2 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

European ethnicity
Chinese ethnicity
age 19-59 years

Exclusion Criteria:

diabetics
serious blood born infection
haemophilia

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

59 Years

Standard Ages

Adult

Study Population

Health adults, male and female between the ages of 19 and 59

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Trevor Simper, DProf	Contact	00 44 2250000	3978	t.simper@shu.ac.uk
Trevor Simper, DProf	Contact	0044 2250000	3978	t.simper@shu.ac.uk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheffield Hallam Univeristy Food and Nutrition laboratory	Recruiting	Sheffield	South Yorkshire	S1 1WB	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided