HyperglycemiaNCT02852044
The Influence of Sampling Site When Assessing Glucose Tolerance or Insulin Sensitivity With Oral Glucose Ingestion
A study testing Rest, Exercise and Dorsal Hand Vein Cannulation (heated hand technique) in people with Hyperglycemia and Insulin Sensitivity, run by University of Bath at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia, Insulin Sensitivity
- What is being tested?
- Rest, Exercise and Dorsal Hand Vein Cannulation (heated hand technique)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-49 years
- Able and willing to safely comply with all study procedures
- Able to provide written informed consent for participation
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department for Health, University of Bath
Bath, Bath, BA2 7AY
About this study
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
- Being tested
- Rest, Exercise, Dorsal Hand Vein Cannulation (heated hand technique), Venous Cannulation
- Medical subject headings
- Hyperglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RestBehavioural
Allowed to watch television or read for one hour prior to oral glucose tolerance test
ExerciseBehavioural
One hour of cycling at 50% of maximal power output
Dorsal Hand Vein Cannulation (heated hand technique)Other
Venous CannulationOther
| Study group | Role | What they receive |
|---|---|---|
| Rest | Active comparator | Remain rested prior to the oral glucose tolerance test Receives: Behavioral: Rest; Other: Dorsal Hand Vein Cannulation (heated hand technique); Other: Venous Cannulation |
| Exercise | Experimental | Complete exercise prior to the oral glucose tolerance test Receives: Behavioral: Exercise; Other: Dorsal Hand Vein Cannulation (heated hand technique); Other: Venous Cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial plasma glucose concentrations (area under the concentration-time curve)
Measured: 120 mins
OGTT-derived insulin sensitivity
Measured: 120 mins
Secondary outcomes (8)
Fasting plasma glucose concentrations
Measured: 5 mins
Fasting plasma insulin concentrations
Measured: 5 mins
Fasting plasma lactate concentrations
Measured: 5 mins
Fasting plasma triglyceride concentrations
Measured: 5 mins
Postprandial plasma lactate concentrations (area under the concentration-time curve)
Measured: 120 mins
Postprandial plasma triglyceride concentrations (area under the concentration-time curve)
Measured: 120 mins
Substrate utilization for energy provision
Measured: 180 mins
Postprandial plasma insulin concentrations (area under the concentration-time curve)
Measured: 120 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startNov 2015
- Primary completionApr 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Gonzalez, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852044
- Sponsor's protocol ID
- RE-CP
- Status last verified
- Oct 2016
- First submitted
- 28 Jul 2016
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 1395446Liu 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.
PubMed 1563586
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Sampling Site When Assessing Glucose Tolerance or Insulin Sensitivity With Oral Glucose Ingestion
- ClinicalTrials.gov ID
- NCT02852044
- Acronym / sponsor ID
- RE-CP
- Conditions
- Hyperglycemia, Insulin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 2 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rest | Active comparator | Behavioral: Rest, Other: Dorsal Hand Vein Cannulation (heated hand technique), Other: Venous CannulationRemain rested prior to the oral glucose tolerance test |
| Exercise | Experimental | Behavioral: Exercise, Other: Dorsal Hand Vein Cannulation (heated hand technique), Other: Venous CannulationComplete exercise prior to the oral glucose tolerance test |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18-49 years
- Able and willing to safely comply with all study procedures
- Able to provide written informed consent for participation
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RestAllowed to watch television or read for one hour prior to oral glucose tolerance test | Behavioural | Rest |
| ExerciseOne hour of cycling at 50% of maximal power output | Behavioural | Exercise |
| Dorsal Hand Vein Cannulation (heated hand technique) | Other | Exercise, Rest |
| Venous Cannulation | Other | Exercise, Rest |
Primary outcome
Postprandial plasma glucose concentrations (area under the concentration-time curve)
Time frame: 120 mins
OGTT-derived insulin sensitivity
Time frame: 120 mins
8 secondary outcomes
Fasting plasma glucose concentrations
Time frame: 5 mins
Fasting plasma insulin concentrations
Time frame: 5 mins
Fasting plasma lactate concentrations
Time frame: 5 mins
Fasting plasma triglyceride concentrations
Time frame: 5 mins
Postprandial plasma lactate concentrations (area under the concentration-time curve)
Time frame: 120 mins
Postprandial plasma triglyceride concentrations (area under the concentration-time curve)
Time frame: 120 mins
Substrate utilization for energy provision
Time frame: 180 mins
Postprandial plasma insulin concentrations (area under the concentration-time curve)
Time frame: 120 mins
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Background: PubMed 1395446Nauck 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.
- Background: PubMed 1563586Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rest, Exercise and Dorsal Hand Vein Cannulation (heated hand technique) in people with Hyperglycemia and Insulin Sensitivity, run by University of Bath at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial plasma glucose concentrations (area under the concentration-time curve) (time frame: 120 mins). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02852044, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.