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The Influence of Sampling Site When Assessing Glucose Tolerance or Insulin Sensitivity With Oral Glucose Ingestion

NCT ID: NCT02852044

Last Updated: 2016-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-09-30

Brief Summary

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For decades, it has been known that post-meal blood glucose concentrations were associated with the risk of T2D, which was reflected in early diagnostic guidelines. The oral glucose tolerance test (OGTT) has been used since at least 1923 and has remained the most common test for assessing glucose tolerance. Arterial blood (or arterialised blood using heated hand technique) is most appropriate for determining glucose tolerance and insulin sensitivity since this best represents the concentrations of metabolites and hormones that peripheral tissues are exposed to. It is essential to investigate whether venous blood (sometimes used during an OGTT) is representative of arterialised blood during an OGTT, and under different metabolic conditions.

The investigators want to understand whether OGTT-derived insulin sensitivity indices differ from venous and arterialised blood; and 2) investigate whether metabolic status (i.e. rest vs lower-limb exercise) influences the difference between forearm venous and arterialised concentrations of glucose and insulin during an OGTT.

Detailed Description

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Conditions

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Hyperglycemia Insulin Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Rest

Remain rested prior to the oral glucose tolerance test

Group Type ACTIVE_COMPARATOR

Rest

Intervention Type BEHAVIORAL

Allowed to watch television or read for one hour prior to oral glucose tolerance test

Dorsal Hand Vein Cannulation (heated hand technique)

Intervention Type OTHER

Venous Cannulation

Intervention Type OTHER

Exercise

Complete exercise prior to the oral glucose tolerance test

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

One hour of cycling at 50% of maximal power output

Dorsal Hand Vein Cannulation (heated hand technique)

Intervention Type OTHER

Venous Cannulation

Intervention Type OTHER

Interventions

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Rest

Allowed to watch television or read for one hour prior to oral glucose tolerance test

Intervention Type BEHAVIORAL

Exercise

One hour of cycling at 50% of maximal power output

Intervention Type BEHAVIORAL

Dorsal Hand Vein Cannulation (heated hand technique)

Intervention Type OTHER

Venous Cannulation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Aged 18-49 years
* Able and willing to safely comply with all study procedures
* Able to provide written informed consent for participation

Exclusion Criteria

* Diagnosis of any bleeding disorder or taking medication which impacts blood coagulation
* The presence of any contraindications to maximal exercise testing, as determined using a physical activity readiness questionnaire (PAR-Q).
* Any diagnosis of metabolic disease (i.e. cardiovascular disease or type 2 diabetes).
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bath

OTHER

Sponsor Role lead

Responsible Party

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Javier Gonzalez

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department for Health, University of Bath

Bath, Bath, United Kingdom

Site Status

Countries

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United Kingdom

References

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Nauck MA, Liess H, Siegel EG, Niedmann PD, Creutzfeldt W. Critical evaluation of the 'heated-hand-technique' for obtaining 'arterialized' venous blood: incomplete arterialization and alterations in glucagon responses. Clin Physiol. 1992 Sep;12(5):537-52. doi: 10.1111/j.1475-097x.1992.tb00357.x.

Reference Type BACKGROUND
PMID: 1395446 (View on PubMed)

Liu D, Moberg E, Kollind M, Lins PE, Adamson U, Macdonald IA. Arterial, arterialized venous, venous and capillary blood glucose measurements in normal man during hyperinsulinaemic euglycaemia and hypoglycaemia. Diabetologia. 1992 Mar;35(3):287-90. doi: 10.1007/BF00400932.

Reference Type BACKGROUND
PMID: 1563586 (View on PubMed)

Other Identifiers

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RE-CP

Identifier Type: -

Identifier Source: org_study_id