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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Insulin Sensitivity
• Intervention / Treatment: Behavioral: Rest; Other: Dorsal Hand Vein Cannulation (heated hand technique); Other: Venous Cannulation; Behavioral: Exercise

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bath, United Kingdom, BA2 7AY
    • Department for Health, University of Bath

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Rest; Remain rested prior to the oral glucose tolerance test	Behavioral: Rest; Allowed to watch television or read for one hour prior to oral glucose tolerance test; Other: Dorsal Hand Vein Cannulation (heated hand technique); Other: Venous Cannulation
EXPERIMENTAL: Exercise; Complete exercise prior to the oral glucose tolerance test	Other: Dorsal Hand Vein Cannulation (heated hand technique); Other: Venous Cannulation; Behavioral: Exercise; One hour of cycling at 50% of maximal power output

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Bath

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (ACTUAL): April 1, 2016
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: August 1, 2016
• First Posted (ESTIMATE): August 2, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): October 25, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Hyperinsulinism; Hyperglycemia; Hypersensitivity; Insulin Resistance
• Other Study ID Numbers: RE-CP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO