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

NCT02852044 | Completed

• 1 other identifier: RE-CP
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperglycemia; Insulin Sensitivity

Outcome Measures

Primary Outcomes (2)

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

  120 mins

• OGTT-derived insulin sensitivity

  120 mins

Secondary Outcomes (8)

• 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

Study Arms (2)

Rest

ACTIVE COMPARATOR

Remain rested prior to the oral glucose tolerance test

Behavioral: Rest; Other: Dorsal Hand Vein Cannulation (heated hand technique); Other: Venous Cannulation

Exercise

EXPERIMENTAL

Complete exercise prior to the oral glucose tolerance test

Behavioral: Exercise; Other: Dorsal Hand Vein Cannulation (heated hand technique); Other: Venous Cannulation

Interventions

Rest BEHAVIORAL

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

Rest

Exercise BEHAVIORAL

One hour of cycling at 50% of maximal power output

Exercise

Dorsal Hand Vein Cannulation (heated hand technique) OTHER

Exercise; Rest

Venous Cannulation OTHER

Exercise; Rest

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18-49 years
• Able and willing to safely comply with all study procedures
• Able to provide written informed consent for participation

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Bath: lead

Study Sites (1)

Department for Health, University of Bath

Bath, Bath, BA2 7AY, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 1395446 BACKGROUND

• 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.

  PMID: 1563586 BACKGROUND

MeSH Terms

Conditions

Hyperglycemia; Insulin Resistance

Interventions

RE1-silencing transcription factor; Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 2, 2016
• Study Start: November 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 25, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)