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

Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02852044
• Other study ID #: RE-CP
• Status: Completed
• Phase: N/A
• First received: July 28, 2016
• Last updated: October 24, 2016
• Start date: November 2015
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: University of Bath
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 49 Years

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hyperglycemia
• Hypersensitivity
• Insulin Resistance
• Insulin Sensitivity

Intervention

Behavioral:
• Rest
Allowed to watch television or read for one hour prior to oral glucose tolerance test
• Exercise
One hour of cycling at 50% of maximal power output

Other:
• Dorsal Hand Vein Cannulation (heated hand technique)

• Venous Cannulation

Locations

Country	Name	City	State
United Kingdom	Department for Health, University of Bath	Bath

Sponsors (1)

Lead Sponsor	Collaborator
University of Bath

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial plasma glucose concentrations (area under the concentration-time curve)		120 mins	No
Primary	OGTT-derived insulin sensitivity		120 mins	No
Secondary	Fasting plasma glucose concentrations		5 mins	No
Secondary	Fasting plasma insulin concentrations		5 mins	No
Secondary	Fasting plasma lactate concentrations		5 mins	No
Secondary	Fasting plasma triglyceride concentrations		5 mins	No
Secondary	Postprandial plasma lactate concentrations (area under the concentration-time curve)		120 mins	No
Secondary	Postprandial plasma triglyceride concentrations (area under the concentration-time curve)		120 mins	No
Secondary	Substrate utilization for energy provision		180 mins	No
Secondary	Postprandial plasma insulin concentrations (area under the concentration-time curve)		120 mins	No