Clinical trial NCT02852044: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia
Insulin Sensitivity
Lead sponsor: University of Bath
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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).

Primary outcomes:
measure: Postprandial plasma glucose concentrations (area under the concentration-time curve)
timeFrame: 120 mins
measure: OGTT-derived insulin sensitivity
timeFrame: 120 mins
Secondary outcomes:
measure: Fasting plasma glucose concentrations
timeFrame: 5 mins
measure: Fasting plasma insulin concentrations
timeFrame: 5 mins
measure: Fasting plasma lactate concentrations
timeFrame: 5 mins
measure: Fasting plasma triglyceride concentrations
timeFrame: 5 mins
measure: Postprandial plasma lactate concentrations (area under the concentration-time curve)
timeFrame: 120 mins
measure: Postprandial plasma triglyceride concentrations (area under the concentration-time curve)
timeFrame: 120 mins
measure: Substrate utilization for energy provision
timeFrame: 180 mins
measure: Postprandial plasma insulin concentrations (area under the concentration-time curve)
timeFrame: 120 mins
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: Department for Health, University of Bath
Study officials:
References:
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.
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.