Diabetes Mellitus, Type 2NCT01144520
Leukocyte Dysfunction in Diabetic Patients.
An observational study of Diabetes Mellitus, Type 2, run by Sashwati Roy at 1 site in United States.
Trial summary
The purpose of this study is to study impairment of white blood cell function in patients with type II diabetes. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Dec 2018
- Phase
- Observational
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects will be recruited from the population who visit the Ohio State University (OSU) Hospitals and Comprehensive Wound Center (CWC), OSU Wexner Medical Center diabetic clinics and Bariatric clinic.
Who may be able to join
- Adults ages 40-60 yrs old clinically diagnosed with Type II Diabetes
- Adults ages 40-60 yrs old without Diabetes
Who cannot join
- Unable to provide informed consent
- Pregnant Females
- Therapeutically Immuno-compromised
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Wound Center
Columbus, Ohio, 43221
About this study
The purpose of this study is to study impairment of white blood cell function in patients with type II diabetes.
Read the detailed description
Leucocytes from poorly controlled diabetes exhibit aberrant chemotaxis, increased susceptibility to bacterial infection, leukotriene production, lysosomal enzyme release, proinflammatory cytokine expression and production of reactive oxygen species. Aberrant glucose concentration in diabetics affects functions of peripheral blood system as well as the immune system leading to impaired host defense. Impaired wound healing is a serious complication associated with diabetes. We hypothesized that impairment in leukocyte function results in dysfunctional inflammatory response in diabetic wounds. The proposed studies focus on characterizing mechanisms that will improve our understanding of the dysfunctional inflammatory response resulting in non-healing chronic wounds in diabetics.
- Conditions
- Diabetes Mellitus, Type 2
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Normoglycemic | Healthy subjects that do not have diabetes | |
| Type II Diabetes (HbA1c <7 or 7%) | Subject that have Type II Diabetes with good glucose control with glycated hemoglobin (HbA1c <7 or 7%) | |
| Type II Diabetes (HbA1c between 7.1-9) | Subjects with Type II Diabetes with moderate glucose control (HbA1c between 7.1-9) | |
| Type II Diabetes (HbA1c >9%) | Subjects with Type II Diabetes with poor glucose control (HbA1c >9%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ex vivo leukocyte function by measuring ROS production
After blood draw monocytes are separated from whole blood and production of oxidants by these cells
Measured: immediately after blood draw
Secondary outcomes (1)
Ex vivo NADPH oxidase gene and protein expression
Gene and protein expressions are measured using Western blot and real time PCR.
Measured: After blood draw
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: researchers moved to new institution and did not transfer project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sashwati Roy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sashwati Roy, Ohio State University
- Investigators
- Roy Sashwati, MS, PhD, Principal investigator, Ohio State University Dept of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144520
- Sponsor's protocol ID
- 2009H0270
- Status last verified
- Nov 2021
- First submitted
- 14 Jun 2010
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Shurtz-Swirski R, Sela S, Herskovits AT, Shasha SM, Shapiro G, Nasser L, Kristal B. Involvement of peripheral polymorphonuclear leukocytes in oxidative stress and inflammation in type 2 diabetic patients. Diabetes Care. 2001 Jan;24(1):104-10. doi: 10.2337/diacare.24.1.104.
PubMed 11194213Lin X, Candlish JK, Thai AC. Superoxide production by neutrophils from diabetics and normal subjects in response to glucose and galactose. Exp Mol Pathol. 1993 Jun;58(3):229-36. doi: 10.1006/exmp.1993.1020.
PubMed 8390941Molenaar DM, Palumbo PJ, Wilson WR, Ritts RE Jr. Leukocyte chemotaxis in diabetic patients and their nondiabetic first-degree relatives. Diabetes. 1976;25(2 SUPPL):880-3.
PubMed 971792Hill HR, Sauls HS, Dettloff JL, Quie PG. Impaired leukotactic responsiveness in patients with juvenile diabetes mellitus. Clin Immunol Immunopathol. 1974 Apr;2(3):395-403. doi: 10.1016/0090-1229(74)90057-9. No abstract available.
PubMed 4826528
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leukocyte Dysfunction in Diabetic Patients.
- ClinicalTrials.gov ID
- NCT01144520
- Acronym / sponsor ID
- 2009H0270
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: researchers moved to new institution and did not transfer project
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Sashwati RoyUniversity, hospital or other
- Study start
- Mar 2010 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 15 Jun 2010 (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 study impairment of white blood cell function in patients with type II diabetes.
Detailed description
Leucocytes from poorly controlled diabetes exhibit aberrant chemotaxis, increased susceptibility to bacterial infection, leukotriene production, lysosomal enzyme release, proinflammatory cytokine expression and production of reactive oxygen species. Aberrant glucose concentration in diabetics affects functions of peripheral blood system as well as the immune system leading to impaired host defense. Impaired wound healing is a serious complication associated with diabetes. We hypothesized that impairment in leukocyte function results in dysfunctional inflammatory response in diabetic wounds. The proposed studies focus on characterizing mechanisms that will improve our understanding of the dysfunctional inflammatory response resulting in non-healing chronic wounds in diabetics.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normoglycemic | – | –Healthy subjects that do not have diabetes |
| Type II Diabetes (HbA1c <7 or 7%) | – | –Subject that have Type II Diabetes with good glucose control with glycated hemoglobin (HbA1c <7 or 7%) |
| Type II Diabetes (HbA1c between 7.1-9) | – | –Subjects with Type II Diabetes with moderate glucose control (HbA1c between 7.1-9) |
| Type II Diabetes (HbA1c >9%) | – | –Subjects with Type II Diabetes with poor glucose control (HbA1c >9%) |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects will be recruited from the population who visit the Ohio State University (OSU) Hospitals and Comprehensive Wound Center (CWC), OSU Wexner Medical Center diabetic clinics and Bariatric clinic.
Key inclusion criteria (2 listed)
- Adults ages 40-60 yrs old clinically diagnosed with Type II Diabetes
- Adults ages 40-60 yrs old without Diabetes
Key exclusion criteria (3 listed)
- Unable to provide informed consent
- Pregnant Females
- Therapeutically Immuno-compromised
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ex vivo leukocyte function by measuring ROS production
Time frame: immediately after blood draw
After blood draw monocytes are separated from whole blood and production of oxidants by these cells
1 secondary outcome
Ex vivo NADPH oxidase gene and protein expression
Time frame: After blood draw
Results and safety
The study was stopped early (reason given: researchers moved to new institution and did not transfer project). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Results publication: PubMed 11194213Shurtz-Swirski R, Sela S, Herskovits AT, Shasha SM, Shapiro G, Nasser L, Kristal B. Involvement of peripheral polymorphonuclear leukocytes in oxidative stress and inflammation in type 2 diabetic patients. Diabetes Care. 2001 Jan;24(1):104-10. doi: 10.2337/diacare.24.1.104.
- Results publication: PubMed 8390941Lin X, Candlish JK, Thai AC. Superoxide production by neutrophils from diabetics and normal subjects in response to glucose and galactose. Exp Mol Pathol. 1993 Jun;58(3):229-36. doi: 10.1006/exmp.1993.1020.
- Results publication: PubMed 971792Molenaar DM, Palumbo PJ, Wilson WR, Ritts RE Jr. Leukocyte chemotaxis in diabetic patients and their nondiabetic first-degree relatives. Diabetes. 1976;25(2 SUPPL):880-3.
- Results publication: PubMed 4826528Hill HR, Sauls HS, Dettloff JL, Quie PG. Impaired leukotactic responsiveness in patients with juvenile diabetes mellitus. Clin Immunol Immunopathol. 1974 Apr;2(3):395-403. doi: 10.1016/0090-1229(74)90057-9. No abstract available.
- OSU Center for Regenerative Medicine and Cell Based TherapiesLink provided by the sponsor.
- OSU Comprehensive Wound CenterLink provided by the sponsor.
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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.
Roy Sashwati, MS, PhD principal investigator
Ohio State University Dept of Surgery
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 Mellitus, Type 2, run by Sashwati Roy 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 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: stopped early, as of the sponsor's last update on 22 Nov 2021. 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?
The study was stopped early (reason given: researchers moved to new institution and did not transfer project). Results are not available in the source record.
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?
Ex vivo leukocyte function by measuring ROS production (time frame: immediately after blood draw). 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 NCT01144520, which also lists 4 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 22 Nov 2021; AzTrials last refreshed its copy on 2 Nov 2026.