Type 2 DiabetesEarly Phase 1NCT00829699
Metabolic Causes of Thrombosis in Type 2 Diabetes Mellitus
A Early Phase 1 study testing euinsulinemic euglycemic glucose clamp, euinsulinemic hyperglycemic glucose clamp and Hyperinsulinemic euglycemic glucose clamp in people with Type 2 Diabetes, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The purpose of this study is to learn more about why patients with diabetes have increased heart attacks, strokes and other illnesses due to blood clots causing blockage of a blood vessel. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- euinsulinemic euglycemic glucose clamp, euinsulinemic hyperglycemic glucose clamp and Hyperinsulinemic euglycemic glucose clamp
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Apr 2014
- Phase
- Early Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 16 Type 2 diabetic patients age 18 - 60 yrs
- 16 Non-diabetic controls age 18-60 yrs
- Body mass index >20 kg/m2
- Female volunteers of childbearing potential: negative urine pregnancy test
- Volunteers over 40 years old: an ECG with no clinically significant conduction or ischemic changes.
- For those with type 2 diabetes: HBA1C > 5.5%
- For those with type 2 diabetes: C-peptide >0.2 nmol, If C-peptide is abnormal or there is a clinical suspicion for type 1 diabetes, MODY or LADA, anti-islet cell and anti-GAD antibodies will be assessed to establish the diagnosis of type 2 diabetes vs. type 1/LADA/MODY.
- PT (time) 12.8-14.6 seconds, PTT (time) 25-38 seconds
Who cannot join
- Any current disease condition that alters carbohydrate metabolism (other than type 2 DM) and/or evidence for clinically significant cardiac disease
- Uncontrolled hypertension
- Pregnancy
- Subjects unable to give voluntary informed consent
- Subjects with history of pancreatitis
- Subjects on anticoagulant drugs, anemic, or with known bleeding diseases
Show all 21Show fewer
- Subjects with history of GI bleeding requiring treatment
- Tobacco Use
- Subjects with history of heparin-induced thrombocytopenia or heparin allergy
- Subjects with severe egg or legume (soybean) allergy
- Abnormal results following screening tests and physical examination that is clinically significant:
- Medical history/Physical Exam Exclusion Criteria
- Fever greater than 38 degrees C at screening or study initiation
- Uncontrolled severe hypertension (i.e., blood pressure greater than 160/100)
- Cardiac Abnormalities (e.g. Heart Failure, Arrhythmia, Cardiomyopathy, ischemic tachycardia, S-T segment deviations, etc.,) from history or ECG testing in subjects > 40 years old.
- Diagnosed Pneumonia
- Hepatic Failure/Jaundice
- Clinically significant coagulopathy
- Renal Failure
- Acute Cerebrovascular/ Neurological deficit
- Screening Laboratory Tests Exclusion Criteria according to protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Univerisity of Maryland, Baltimore
Baltimore, Maryland, 21201
About this study
Official title: Metabolic Causes of Thrombosis in Type 2 Diabetes Mellitus, Question 3
The purpose of this study is to learn more about why patients with diabetes have increased heart attacks, strokes and other illnesses due to blood clots causing blockage of a blood vessel. The proposed protocol will study the separate and combined effects of high glucose and high fats on certain cardiovascular responses in Type 2 DM.
Read the detailed description
Currently 75-80% of diabetes mellitus (DM) patients die due to thrombotic causes. Data from the Centers for Disease Control and Prevention released in 2000 indicated that mortality due to coronary artery disease is decreasing except in individuals with diabetes. Clearly the disordered metabolism, which includes abnormal metabolism of fats resulting in higher triglyceride and free fatty acid blood levels, occurring in diabetes predisposes these individuals to increased thrombotic events. Unless the underlying mechanisms responsible for these events can be identified, there will be an unprecedented number of diabetic patients suffering thrombotic episodes in the next 10 years.
The specific aims of this study are to determine the effects of elevated free fatty acids and hyperglycemia (high glucose)on endothelial function and thrombolytic balance in patients with type 2 diabetes, and to determine the effects of increased insulin in this setting.
- Conditions
- Type 2 Diabetes
- Being tested
- euinsulinemic euglycemic glucose clamp, euinsulinemic hyperglycemic glucose clamp, Hyperinsulinemic euglycemic glucose clamp, Hyperinsulinemic hyperglycemic glucose clamp
- Keywords
- endothelial function, fibrinolytic balance
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
euinsulinemic euglycemic glucose clampProcedure or surgery
Also called Intralipid
euinsulinemic euglycemic glucose clamp with lipid infusion 48 ml/hr for 4 hours
euinsulinemic hyperglycemic glucose clampProcedure or surgery
Also called Intralipid
euinsulinemic hyperglycemic glucose clamp with lipid infusion at 48 ml/hr for 4 hours
Hyperinsulinemic euglycemic glucose clampProcedure or surgery
Also called Intralipid
Hyperinsulinemic euglycemic glucose clamp with lipid infusion at 48 ml/hr for 4 hours
Hyperinsulinemic hyperglycemic glucose clampProcedure or surgery
Also called Intralipid
Hyperinsulinemic hyperglycemic glucose clamp with lipid infusion at 48 ml/hr for 4 hours
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Euinsulinemic (low insulin infusion) Euglycemic (normal blood glucose levels) glucose clamp with lipid (fat) infusion Receives: Procedure: euinsulinemic euglycemic glucose clamp |
| 2 | Experimental | Euinsulinemic Hyperglycemic (high glucose levels) glucose clamp with lipid infusion Receives: Procedure: euinsulinemic hyperglycemic glucose clamp |
| 3 | Experimental | Hyperinsulinemic (High dose insulin) euglycemic glucose clamp with lipid infusion Receives: Procedure: Hyperinsulinemic euglycemic glucose clamp |
| 4 | Experimental | Hyperinsulinemic hyperglycemic (high glucose level) glucose clamp with lipid infusion Receives: Procedure: Hyperinsulinemic hyperglycemic glucose clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in flow mediated dilation of brachial artery
Measured: 4 hours
Secondary outcomes (1)
Change in Lipid measures
Measured: 4hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Stephen N. Davis, MBBS, University of Maryland, Baltimore
- Investigators
- Stephen N. Davis, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829699
- Sponsor's protocol ID
- HP-00044874
- Other IDs
- RFAHL04016
- Status last verified
- Sep 2019
- First submitted
- 23 Jan 2009
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Causes of Thrombosis in Type 2 Diabetes Mellitus, Question 3
- ClinicalTrials.gov ID
- NCT00829699
- Acronym / sponsor ID
- HP-00044874
- Conditions
- Type 2 Diabetes
- Keywords
- endothelial function, fibrinolytic balance
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 27 Jan 2009 (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.
The purpose of this study is to learn more about why patients with diabetes have increased heart attacks, strokes and other illnesses due to blood clots causing blockage of a blood vessel. The proposed protocol will study the separate and combined effects of high glucose and high fats on certain cardiovascular responses in Type 2 DM.
Detailed description
Currently 75-80% of diabetes mellitus (DM) patients die due to thrombotic causes. Data from the Centers for Disease Control and Prevention released in 2000 indicated that mortality due to coronary artery disease is decreasing except in individuals with diabetes. Clearly the disordered metabolism, which includes abnormal metabolism of fats resulting in higher triglyceride and free fatty acid blood levels, occurring in diabetes predisposes these individuals to increased thrombotic events. Unless the underlying mechanisms responsible for these events can be identified, there will be an unprecedented number of diabetic patients suffering thrombotic episodes in the next 10 years.
The specific aims of this study are to determine the effects of elevated free fatty acids and hyperglycemia (high glucose)on endothelial function and thrombolytic balance in patients with type 2 diabetes, and to determine the effects of increased insulin in this setting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: euinsulinemic euglycemic glucose clampEuinsulinemic (low insulin infusion) Euglycemic (normal blood glucose levels) glucose clamp with lipid (fat) infusion |
| 2 | Experimental | Procedure: euinsulinemic hyperglycemic glucose clampEuinsulinemic Hyperglycemic (high glucose levels) glucose clamp with lipid infusion |
| 3 | Experimental | Procedure: Hyperinsulinemic euglycemic glucose clampHyperinsulinemic (High dose insulin) euglycemic glucose clamp with lipid infusion |
| 4 | Experimental | Procedure: Hyperinsulinemic hyperglycemic glucose clampHyperinsulinemic hyperglycemic (high glucose level) glucose clamp with lipid infusion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 16 Type 2 diabetic patients age 18 - 60 yrs
- 16 Non-diabetic controls age 18-60 yrs
- Body mass index >20 kg/m2
- Female volunteers of childbearing potential: negative urine pregnancy test
- Volunteers over 40 years old: an ECG with no clinically significant conduction or ischemic changes.
Key exclusion criteria (21 listed)
- Any current disease condition that alters carbohydrate metabolism (other than type 2 DM) and/or evidence for clinically significant cardiac disease
- Uncontrolled hypertension
- Pregnancy
- Subjects unable to give voluntary informed consent
- Subjects with history of pancreatitis
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 |
|---|---|---|
| euinsulinemic euglycemic glucose clampAlso: Intralipideuinsulinemic euglycemic glucose clamp with lipid infusion 48 ml/hr for 4 hours | Procedure or surgery | 1 |
| euinsulinemic hyperglycemic glucose clampAlso: Intralipideuinsulinemic hyperglycemic glucose clamp with lipid infusion at 48 ml/hr for 4 hours | Procedure or surgery | 2 |
| Hyperinsulinemic euglycemic glucose clampAlso: IntralipidHyperinsulinemic euglycemic glucose clamp with lipid infusion at 48 ml/hr for 4 hours | Procedure or surgery | 3 |
| Hyperinsulinemic hyperglycemic glucose clampAlso: IntralipidHyperinsulinemic hyperglycemic glucose clamp with lipid infusion at 48 ml/hr for 4 hours | Procedure or surgery | 4 |
Primary outcome
Percent change in flow mediated dilation of brachial artery
Time frame: 4 hours
1 secondary outcome
Change in Lipid measures
Time frame: 4hours
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 12 Sep 2019.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Stephen N. Davis, MD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing euinsulinemic euglycemic glucose clamp, euinsulinemic hyperglycemic glucose clamp and Hyperinsulinemic euglycemic glucose clamp in people with Type 2 Diabetes, run by University of Maryland, Baltimore 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 8 inclusion and 21 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 12 Sep 2019. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percent change in flow mediated dilation of brachial artery (time frame: 4 hours). 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 12 Sep 2019.