Diabetes Mellitus, Type 2NCT01729130
Adipose Tissue Function After Pancreas Transplantation
An observational study of Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
Clinical measures of adipose tissue mass (BMI, waist circumference, waist-to-hip ratio) do not adequately explain the inter-individual and ethnic heterogeneity in diabetes. . There is a need to identify novel/universal markers of risk for diabetes (DM) and cardiovascular disease (CVD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, End Stage Renal Disease
- What is being tested?
- Adipose tissue biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to 19 Feb 2019
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that have Diabetes mellitis and End Stage Renal Disease who will be receiving pancreas/kidney or only kidney transplantation. Patients that have End Stage Renal Disease and who will be receiving an isolated kidney transplant. This control group will account for effects of immuno-suppression and for potential metabolic changes induced by the kidney transplant on adipose tissue function.
Who may be able to join
- Men and women of any ethnicity, and age between 18 and 65 years.
- Patients with diabetes and renal failure who have been scheduled kidney-pancreas or isolated kidney transplantation.
- Ability to speak read and understand English or Spanish
Who cannot join
- Any evidence of acute or severe cardiopulmonary, thyroid, neurological disorders, as assessed by history and physical examination and laboratory testing.
- Any personal history of substance abuse (reported only).
- Alcohol intake above 7 grams/day.
- Pregnancy or lactation.
- Inability to give consent for this study.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Medical Branch (UTMB)
Galveston, Texas, 77555
About this study
Official title: A Pilot Study to Identify the Differences in Adipose Tissue Function After Restoring Normal Glycemic Control Following Pancreas Transplantation
Clinical measures of adipose tissue mass (BMI, waist circumference, waist-to-hip ratio) do not adequately explain the inter-individual and ethnic heterogeneity in diabetes. . There is a need to identify novel/universal markers of risk for diabetes (DM) and cardiovascular disease (CVD). These biomarkers also can become additional outcome measures for an intervention such as pancreatic/kidney transplant. If biological markers show an improvement with an intervention before anthropometric changes occur, intermediate outcomes can be an encouraging finding for practitioners. This study will focus on the central question of "adipose tissue dysfunction" as mediator of metabolic complications of positive energy balance, independent of body fat content and distribution. This study will address the question of effect of hyperglycemia on adipose tissue function independent of body fat mass. This project will take advantage of unique expertise of our investigators to perform detailed metabolic studies in patients with diabetes who undergo pancreatic/kidney transplant. The results of the proposed study will provide support to the novel approach of identifying adipose tissue dysfunction, rather than obesity and fat distribution, as predictor of diabetes and CVD across all ethnic groups, age and gender. We will obtain necessary preliminary data for future grant submissions to support our central hypothesis and develop stronger interactions within and outside The University of Texas Medical Branch (UTMB) with clinical investigators in the area of DM and its complications.
Read the detailed description
detailed description is his protocol
- Being tested
- Adipose tissue biopsy
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose tissue biopsyProcedure or surgery
Adipose tissue biopsy is done at time of transplant surgery. There is a second needle biopsy done between 3-12 months post transplant surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Pancreas/kidney transplant | Group 1 of patients with End Stage Renal Disease (ESRD) and Diabetes Mellitis who will receive a pancreas and kidney transplant. An adipose tissue biopsy and blood samples are collected at time of transplant surgery. A repeat adipose tissue needle biopsy and blood samples are collected between 3-12 months post transplant. Receives: Procedure: Adipose tissue biopsy | |
| Group 2 DM with kidney transplant | Group 2 are patient with DM and ESRD and who will receive only a kidney transplant. Receives: Procedure: Adipose tissue biopsy | |
| Group 3 No DM and kidney transplant | Group 3 will be patients who do not have DM but do have the diagnosis of ESRD and will receive only a kidney transplant. Receives: Procedure: Adipose tissue biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body fat distribution
skinfold thickness changes from baseline to within 1 year post transplantation using tape measure, scale and calipers
Measured: 1 year post transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startSep 2009
- Primary completionSep 2012
- Study completion19 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Cicalese, MD, Principal investigator, UTMB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729130
- Sponsor's protocol ID
- IRB 09-043
- Status last verified
- Feb 2019
- First submitted
- 13 Nov 2012
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Identify the Differences in Adipose Tissue Function After Restoring Normal Glycemic Control Following Pancreas Transplantation
- ClinicalTrials.gov ID
- NCT01729130
- Acronym / sponsor ID
- IRB 09-043
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- 19 Feb 2019 (actual)
- First posted
- 20 Nov 2012 (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.
Clinical measures of adipose tissue mass (BMI, waist circumference, waist-to-hip ratio) do not adequately explain the inter-individual and ethnic heterogeneity in diabetes. . There is a need to identify novel/universal markers of risk for diabetes (DM) and cardiovascular disease (CVD). These biomarkers also can become additional outcome measures for an intervention such as pancreatic/kidney transplant. If biological markers show an improvement with an intervention before anthropometric changes occur, intermediate outcomes can be an encouraging finding for practitioners. This study will focus on the central question of "adipose tissue dysfunction" as mediator of metabolic complications of positive energy balance, independent of body fat content and distribution. This study will address the question of effect of hyperglycemia on adipose tissue function independent of body fat mass. This project will take advantage of unique expertise of our investigators to perform detailed metabolic studies in patients with diabetes who undergo pancreatic/kidney transplant. The results of the proposed study will provide support to the novel approach of identifying adipose tissue dysfunction, rather than obesity and fat distribution, as predictor of diabetes and CVD across all ethnic groups, age and gender. We will obtain necessary preliminary data for future grant submissions to support our central hypothesis and develop stronger interactions within and outside The University of Texas Medical Branch (UTMB) with clinical investigators in the area of DM and its complications.
Detailed description
detailed description is his protocol
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 Pancreas/kidney transplant | – | Procedure: Adipose tissue biopsyGroup 1 of patients with End Stage Renal Disease (ESRD) and Diabetes Mellitis who will receive a pancreas and kidney transplant. An adipose tissue biopsy and blood samples are collected at time of transplant surgery. A repeat adipose tissue needle biopsy and blood samples are collected between 3-12 months post transplant. |
| Group 2 DM with kidney transplant | – | Procedure: Adipose tissue biopsyGroup 2 are patient with DM and ESRD and who will receive only a kidney transplant. |
| Group 3 No DM and kidney transplant | – | Procedure: Adipose tissue biopsyGroup 3 will be patients who do not have DM but do have the diagnosis of ESRD and will receive only a kidney transplant. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that have Diabetes mellitis and End Stage Renal Disease who will be receiving pancreas/kidney or only kidney transplantation. Patients that have End Stage Renal Disease and who will be receiving an isolated kidney transplant. This control group will account for effects of immuno-suppression and for potential metabolic changes induced by the kidney transplant on adipose tissue function.
Key inclusion criteria (3 listed)
- Men and women of any ethnicity, and age between 18 and 65 years.
- Patients with diabetes and renal failure who have been scheduled kidney-pancreas or isolated kidney transplantation.
- Ability to speak read and understand English or Spanish
Key exclusion criteria (6 listed)
- Any evidence of acute or severe cardiopulmonary, thyroid, neurological disorders, as assessed by history and physical examination and laboratory testing.
- Any personal history of substance abuse (reported only).
- Alcohol intake above 7 grams/day.
- Pregnancy or lactation.
- Inability to give consent for this study.
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 |
|---|---|---|
| Adipose tissue biopsyAdipose tissue biopsy is done at time of transplant surgery. There is a second needle biopsy done between 3-12 months post transplant surgery. | Procedure or surgery | Group 1 Pancreas/kidney transplant, Group 2 DM with kidney transplant, Group 3 No DM and kidney transplant |
Primary outcome
Change in body fat distribution
Time frame: 1 year post transplantation
skinfold thickness changes from baseline to within 1 year post transplantation using tape measure, scale and calipers
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 1 Mar 2019.
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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.
Luca Cicalese, MD principal investigator
UTMB
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 and Diabetes Mellitus, Type 1, run by The University of Texas Medical Branch, Galveston 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 3 inclusion and 6 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 1 Mar 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.
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?
Change in body fat distribution (time frame: 1 year post transplantation). 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 1 Mar 2019.