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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02852044
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
Javier Gonzalez, University of Bath

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.


Condition or disease Intervention/treatment Phase
Hyperglycemia Insulin Sensitivity Behavioral: Rest Behavioral: Exercise Other: Dorsal Hand Vein Cannulation (heated hand technique) Other: Venous Cannulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Influence of Sampling Site When Assessing Glucose Tolerance or Insulin Sensitivity With Oral Glucose Ingestion
Study Start Date : November 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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
Behavioral: Exercise
One hour of cycling at 50% of maximal power output

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852044


Locations
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United Kingdom
Department for Health, University of Bath
Bath, United Kingdom, BA2 7AY
Sponsors and Collaborators
University of Bath
Publications:
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Responsible Party: Javier Gonzalez, Lecturer, University of Bath
ClinicalTrials.gov Identifier: NCT02852044    
Other Study ID Numbers: RE-CP
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Insulin Resistance
Hyperglycemia
Hypersensitivity
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases