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

Primary Purpose

Hyperglycemia, Insulin Sensitivity

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Rest

Exercise

Dorsal Hand Vein Cannulation (heated hand technique)

Venous Cannulation

About this trial

This is an interventional basic science trial for Hyperglycemia

Eligibility Criteria

18 Years - 49 Years (Adult)MaleAccepts Healthy Volunteers

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).

Sites / Locations

Department for Health, University of Bath

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Rest

Exercise

Arm Description

Remain rested prior to the oral glucose tolerance test

Complete exercise prior to the oral glucose tolerance test

Outcomes

Primary Outcome Measures

Postprandial plasma glucose concentrations (area under the concentration-time curve)

OGTT-derived insulin sensitivity

Secondary Outcome Measures

Fasting plasma glucose concentrations

Fasting plasma insulin concentrations

Fasting plasma lactate concentrations

Fasting plasma triglyceride concentrations

Postprandial plasma lactate concentrations (area under the concentration-time curve)

Postprandial plasma triglyceride concentrations (area under the concentration-time curve)

Substrate utilization for energy provision

Postprandial plasma insulin concentrations (area under the concentration-time curve)

Full Information

NCT ID

NCT02852044

First Posted

July 28, 2016

Last Updated

October 24, 2016

Sponsor

University of Bath

1. Study Identification

Unique Protocol Identification Number

NCT02852044

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

November 2015 (undefined)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Bath

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperglycemia, Insulin Sensitivity

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rest

Arm Type

Active Comparator

Arm Description

Remain rested prior to the oral glucose tolerance test

Arm Title

Exercise

Arm Type

Experimental

Arm Description

Complete exercise prior to the oral glucose tolerance test

Intervention Type

Behavioral

Intervention Name(s)

Rest

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Exercise

Intervention Description

One hour of cycling at 50% of maximal power output

Intervention Type

Other

Intervention Name(s)

Dorsal Hand Vein Cannulation (heated hand technique)

Intervention Type

Other

Intervention Name(s)

Venous Cannulation

Primary Outcome Measure Information:

Title

Postprandial plasma glucose concentrations (area under the concentration-time curve)

Time Frame

120 mins

Title

OGTT-derived insulin sensitivity

Time Frame

120 mins

Secondary Outcome Measure Information:

Title

Fasting plasma glucose concentrations

Time Frame

5 mins

Title

Fasting plasma insulin concentrations

Time Frame

5 mins

Title

Fasting plasma lactate concentrations

Time Frame

5 mins

Title

Fasting plasma triglyceride concentrations

Time Frame

5 mins

Title

Postprandial plasma lactate concentrations (area under the concentration-time curve)

Time Frame

120 mins

Title

Postprandial plasma triglyceride concentrations (area under the concentration-time curve)

Time Frame

120 mins

Title

Substrate utilization for energy provision

Time Frame

180 mins

Title

Postprandial plasma insulin concentrations (area under the concentration-time curve)

Time Frame

120 mins

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Facility Information:

Facility Name

Department for Health, University of Bath

City

Bath

ZIP/Postal Code

BA2 7AY

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

1395446

Citation

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.

Results Reference

background

PubMed Identifier

1563586

Citation

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.

Results Reference

background

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

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