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OpenTrials
Completed

NCT Number: NCT02852044

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

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.

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Key information

Age range

18 year–49 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department for Health, University of Bath

Bath, BA2 7AY, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Rest

Behavioral

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

Exercise

Behavioral

One hour of cycling at 50% of maximal power output

Dorsal Hand Vein Cannulation (heated hand technique)

Other

Venous Cannulation

Other

Primary outcomes

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

    Time frame: 120 mins

  2. OGTT-derived insulin sensitivity

    Time frame: 120 mins

Secondary outcomes

  1. Fasting plasma glucose concentrations

    Time frame: 5 mins

  2. Fasting plasma insulin concentrations

    Time frame: 5 mins

  3. Fasting plasma lactate concentrations

    Time frame: 5 mins

  4. Fasting plasma triglyceride concentrations

    Time frame: 5 mins

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

    Time frame: 120 mins

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

    Time frame: 120 mins

  7. Substrate utilization for energy provision

    Time frame: 180 mins

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

    Time frame: 120 mins

Sponsors and collaborators

Lead sponsor

University of Bath

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 2, 2016
Registry last updated
Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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