Overview

This trial has been completed.

Conditions hyperglycemia, insulin sensitivity
Treatments rest, exercise, dorsal hand vein cannulation (heated hand technique), venous cannulation
Sponsor University of Bath
Start date November 2015
End date April 2016
Trial size 10 participants
Trial identifier NCT02852044, RE-CP

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Primary purpose basic science
Arm
(Active Comparator)
Remain rested prior to the oral glucose tolerance test
rest
Allowed to watch television or read for one hour prior to oral glucose tolerance test
dorsal hand vein cannulation (heated hand technique)
venous cannulation
(Experimental)
Complete exercise prior to the oral glucose tolerance test
exercise
One hour of cycling at 50% of maximal power output
dorsal hand vein cannulation (heated hand technique)
venous cannulation

Primary Outcomes

Measure
Postprandial plasma glucose concentrations (area under the concentration-time curve)
time frame: 120 mins
OGTT-derived insulin sensitivity
time frame: 120 mins

Secondary Outcomes

Measure
Fasting plasma glucose concentrations
time frame: 5 mins
Fasting plasma insulin concentrations
time frame: 5 mins
Fasting plasma lactate concentrations
time frame: 5 mins
Fasting plasma triglyceride concentrations
time frame: 5 mins
Postprandial plasma lactate concentrations (area under the concentration-time curve)
time frame: 120 mins
Postprandial plasma triglyceride concentrations (area under the concentration-time curve)
time frame: 120 mins
Substrate utilization for energy provision
time frame: 180 mins
Postprandial plasma insulin concentrations (area under the concentration-time curve)
time frame: 120 mins

Eligibility Criteria

Male participants from 18 years up to 49 years old.

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).

Additional Information

Official title The Influence of Sampling Site When Assessing Glucose Tolerance or Insulin Sensitivity With Oral Glucose Ingestion
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Bath.