DiabetesNCT02682342
Hyperglycemia and Mitochondrial Function in The Endothelium of Humans
An observational study of Diabetes and Hyperglycemia, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
In this study, the investigators will test the hypothesis that acute in vivo exposure to hyperglycemia increases mitochondrial network fragmentation and mitochondrial reactive oxygen species production (ROS) production in human arterial endothelial cells. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Hyperglycemia
- What is being tested?
- 75 g glucose solution
- Type of treatment
- Pill or oral medicine
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2016to 22 Nov 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects without evidence of diabetes, insulin resistance, hypertension, or elevated cholesterol. Subjects will also be without prevalent cardiovascular disease, chronic renal insufficiency, or chronic liver disease.
Who may be able to join
- Adult age 21 to 70
- No evidence of metabolic syndrome or diabetes, hypertension (BP≥140/90), or high cholesterol (LDL≥160) at the time of screening.
Who cannot join
- History of stroke, peripheral arterial disease, or coronary artery disease (as defined by the presence of at least one coronary stenosis ≥ 40% on angiography or by confirmed history of myocardial infarction by standard criteria).
- History of bleeding disorders.
- Evidence of other evident major illness including chronic renal insufficiency (plasma creatinine > 1.4 for women or 1.5 for men), liver disease (liver enzymes greater than 2.5 x normal), and cancer
- currently undergoing therapy or had therapy for cancer within 1 year of enrollment.
- Pregnancy as determined by urinary human chorionic gonadotropin beta test
- Thienopyridine, anti-thrombin/Xa, or warfarin therapy at time of screening
- On medication for cholesterol or blood pressure
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
In this study, the investigators will test the hypothesis that acute in vivo exposure to hyperglycemia increases mitochondrial network fragmentation and mitochondrial reactive oxygen species production (ROS) production in human arterial endothelial cells.
Read the detailed description
Subjects will be recruited according to our inclusion/exclusion criteria. The investigators employ a multifaceted approach to recruitment, including flyers, community newspaper ads, internet ad postings, and direct recruitment from the Internal Medicine Clinics of Froedtert Memorial Lutheran Hospital/Medical College of Wisconsin which saw approximately 50,000 unique outpatient visits over last year. The electronic health record is leveraged to identify potential subjects by HIPAA guidelines and Medical College of Wisconsin policies. Potential subjects will undergo phenotyping that includes a detailed medical history, anthropomorphic measurements, blood pressure and heart rate measurements, and a blood draw for measurements that include fasting lipids, glucose, and glycosylated hemoglobin, creatinine, and liver function tests. Healthy, non-DM subjects who pass the screening as per the inclusion/exclusion criteria in Table 2 will be enrolled in the study protocol.
Following an overnight fast (12 hours), subjects will come in the morning to our Adult Translational Research Unit (A-TRU) which is part of the Clinical Translational Research Initiative of Southeast Wisconsin (8UL1TR000055). An antecubital intravenous line will be placed to facilitate blood glucose sampling during the hyperglycemic challenge. An antecubital intravenous catheter will be placed to facilitate obtaining endothelial cells from the vein by J-wire biopsy for of mitochondrial testing. The principal investigator has published experience with the J-wire endothelial cell biopsy technique, and the technique has been extensively validated technique. An initial venous glucose sample will be taken from the antecubital vein and an initial J-wire biopsy of the radial artery endothelium will be performed through the radial arterial line. Subjects will then be asked to drink a standardized 75 g glucose drink created by the A-TRU nutritionist- a standard oral glucose challenge as used clinically. Blood glucose samples will be taken hourly after that until 4 hours post drink ingestion. At one and 4 hours post-ingestion, J-wire endothelial biopsies of the radial artery will be repeated. Four separate J wires will be passed into the radial artery for each measurement time point (0,1, and 4 hours).
In non-diabetic subjects, the 75 g oral challenge induces a peak increase in systemic glucose at 1-hour post-administration at which time endothelial dysfunction is concomitantly detectable. Endothelial cells will be obtained via J-wire capture technique. A portion of the endothelial cells isolated from the J-wires will be used to measure mitochondrial network complexity prior hyperglycemic challenge, 1-hour post challenge, and 4 hours post challenge. The investigators will visualize the mitochondrial networks in these cells using our previously reported and validated immunofluorescence method using cytochrome c antibodies to tag the mitochondria. Network fragmentation (high number=greater fragmentation and fission) will be quantified by network fragmentation count calculated with ImageJ (NIH, Bethesda) using a validated protocol.
- Conditions
- Diabetes, Hyperglycemia
- Being tested
- 75 g glucose solution
- Medical subject headings
- Diabetes Mellitus, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
75 g glucose solutionOther
This is the same as the standard oral glucose challenge dose and route given clinically
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Healthy subjects meeting inclusion criteria will be administered a 75 g glucose solution one time (orally). Subjects will be ages 21-70 years with no evidence of diabetes, hypertension, metabolic syndrome, or high cholesterol at the time of screening. Potential subjects with a history of atherosclerotic disease, chronic renal insufficiency (plasma creatinine > 1.5 men, > 1.5 women), liver enzymes > 2.5x normal, pregnant at the time of screening will be excluded Receives: Other: 75 g glucose solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mitochondrial Network Complexity of Endothelial Cells as Measured by Mitochondrial Network Fragment Ratio
The investigators visualize the mitochondrial network complexity in these cells using our previously reported and validated immunofluorescence method using cytochrome c antibodies to tag the mitochondria. Network fragmentation (total number of fragments/ total fluorescent pixels*100) will be quantified by network fragmentation count calculated with ImageJ (NIH, Bethesda) using a validated protocol.
Measured: Measured at 0,1, and 2 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study start9 Mar 2016
- Primary completion28 Feb 2022
- Study completion22 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael E. Widlansky, Medical College of Wisconsin
- Investigators
- Micahel E Widlansky, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682342
- Sponsor's protocol ID
- PRO26013
- Status last verified
- Nov 2024
- First submitted
- 8 Feb 2016
- Last updated
- 10 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: The data may be available to qualified investigators following study completion and initial publication of the data with collaboration with the study PI.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperglycemia and Mitochondrial Function in The Endothelium of Humans
- ClinicalTrials.gov ID
- NCT02682342
- Acronym / sponsor ID
- PRO26013
- Conditions
- Diabetes, Hyperglycemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 9 Mar 2016 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 15 Feb 2016 (estimated)
- Results
- Posted 10 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators will test the hypothesis that acute in vivo exposure to hyperglycemia increases mitochondrial network fragmentation and mitochondrial reactive oxygen species production (ROS) production in human arterial endothelial cells.
Detailed description
Subjects will be recruited according to our inclusion/exclusion criteria. The investigators employ a multifaceted approach to recruitment, including flyers, community newspaper ads, internet ad postings, and direct recruitment from the Internal Medicine Clinics of Froedtert Memorial Lutheran Hospital/Medical College of Wisconsin which saw approximately 50,000 unique outpatient visits over last year. The electronic health record is leveraged to identify potential subjects by HIPAA guidelines and Medical College of Wisconsin policies. Potential subjects will undergo phenotyping that includes a detailed medical history, anthropomorphic measurements, blood pressure and heart rate measurements, and a blood draw for measurements that include fasting lipids, glucose, and glycosylated hemoglobin, creatinine, and liver function tests. Healthy, non-DM subjects who pass the screening as per the inclusion/exclusion criteria in Table 2 will be enrolled in the study protocol.
Following an overnight fast (12 hours), subjects will come in the morning to our Adult Translational Research Unit (A-TRU) which is part of the Clinical Translational Research Initiative of Southeast Wisconsin (8UL1TR000055). An antecubital intravenous line will be placed to facilitate blood glucose sampling during the hyperglycemic challenge. An antecubital intravenous catheter will be placed to facilitate obtaining endothelial cells from the vein by J-wire biopsy for of mitochondrial testing. The principal investigator has published experience with the J-wire endothelial cell biopsy technique, and the technique has been extensively validated technique. An initial venous glucose sample will be taken from the antecubital vein and an initial J-wire biopsy of the radial artery endothelium will be performed through the radial arterial line. Subjects will then be asked to drink a standardized 75 g glucose drink created by the A-TRU nutritionist- a standard oral glucose challenge as used clinically. Blood glucose samples will be taken hourly after that until 4 hours post drink ingestion. At one and 4 hours post-ingestion, J-wire endothelial biopsies of the radial artery will be repeated. Four separate J wires will be passed into the radial artery for each measurement time point (0,1, and 4 hours).
In non-diabetic subjects, the 75 g oral challenge induces a peak increase in systemic glucose at 1-hour post-administration at which time endothelial dysfunction is concomitantly detectable. Endothelial cells will be obtained via J-wire capture technique. A portion of the endothelial cells isolated from the J-wires will be used to measure mitochondrial network complexity prior hyperglycemic challenge, 1-hour post challenge, and 4 hours post challenge. The investigators will visualize the mitochondrial networks in these cells using our previously reported and validated immunofluorescence method using cytochrome c antibodies to tag the mitochondria. Network fragmentation (high number=greater fragmentation and fission) will be quantified by network fragmentation count calculated with ImageJ (NIH, Bethesda) using a validated protocol.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | – | Other: 75 g glucose solutionHealthy subjects meeting inclusion criteria will be administered a 75 g glucose solution one time (orally). Subjects will be ages 21-70 years with no evidence of diabetes, hypertension, metabolic syndrome, or high cholesterol at the time of screening. Potential subjects with a history of atherosclerotic disease, chronic renal insufficiency (plasma creatinine > 1.5 men, > 1.5 women), liver enzymes > 2.5x normal, pregnant at the time of screening will be excluded |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects without evidence of diabetes, insulin resistance, hypertension, or elevated cholesterol. Subjects will also be without prevalent cardiovascular disease, chronic renal insufficiency, or chronic liver disease.
Key inclusion criteria (2 listed)
- Adult age 21 to 70
- No evidence of metabolic syndrome or diabetes, hypertension (BP≥140/90), or high cholesterol (LDL≥160) at the time of screening.
Key exclusion criteria (7 listed)
- History of stroke, peripheral arterial disease, or coronary artery disease (as defined by the presence of at least one coronary stenosis ≥ 40% on angiography or by confirmed history of myocardial infarction by standard criteria).
- History of bleeding disorders.
- Evidence of other evident major illness including chronic renal insufficiency (plasma creatinine > 1.4 for women or 1.5 for men), liver disease (liver enzymes greater than 2.5 x normal), and cancer
- currently undergoing therapy or had therapy for cancer within 1 year of enrollment.
- Pregnancy as determined by urinary human chorionic gonadotropin beta test
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 |
|---|---|---|
| 75 g glucose solutionThis is the same as the standard oral glucose challenge dose and route given clinically | Other | Healthy Subjects |
Primary outcome
Change in Mitochondrial Network Complexity of Endothelial Cells as Measured by Mitochondrial Network Fragment Ratio
Time frame: Measured at 0,1, and 2 hours after administration
The investigators visualize the mitochondrial network complexity in these cells using our previously reported and validated immunofluorescence method using cytochrome c antibodies to tag the mitochondria. Network fragmentation (total number of fragments/ total fluorescent pixels*100) will be quantified by network fragmentation count calculated with ImageJ (NIH, Bethesda) using a validated protocol.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The data may be available to qualified investigators following study completion and initial publication of the data with collaboration with the study PI.
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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.
Micahel E Widlansky, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Hyperglycemia, run by Medical College of Wisconsin at 1 site in United States.
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 2 inclusion and 7 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 10 Jan 2025. 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 States. 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?
Yes. Results are posted in the registry (first posted 10 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Mitochondrial Network Complexity of Endothelial Cells as Measured by Mitochondrial Network Fragment Ratio (time frame: Measured at 0,1, and 2 hours after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2025.