Diabetes Mellitus, Type 2ComB-PAKNCT05576116
Combined Bariatric Surgery and Pancreas After Kidney Transplantation for Type II Diabetics
A study testing Sleeve Gastrectomy AND Pancreas after Kidney Transplantation (Staggered Approach) and Combined Sleeve Gastrectomy and Pancreas transplantation in people with Diabetes Mellitus, Type 2 and Overweight, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of sleeve gastrectomy combined with pancreas after kidney (PAK) transplantation as a means of achieving normoglycemia, insulin independence, reduced insulin resistance, and kidney graft function preservation in the T2DM population. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Overweight
- What is being tested?
- Sleeve Gastrectomy AND Pancreas after Kidney Transplantation (Staggered Approach) and Combined Sleeve Gastrectomy and Pancreas transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 23 Sep 2022to 30 Jun 2026
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Willing and able to provide informed consent
- Females must be post-menopausal, surgically sterile or practicing adequate birth control for the duration of the study period
- Recipient of a kidney graft (either live or deceased donor) due to diabetic nephropathy
- Minimum 6 months post-Kidney transplantation surgery
- BMI >30
- Possess 3 of 4 metabolic syndrome components
Show all 12Show fewer
- Elevated waist circumference (>88cm for women; >102cm for men)
- Elevated Triglycerides (>150mg/dL) or drug treatment for elevated triglycerides
- Low HDL cholesterol (<40mg/dL for men; <50mg/dL for women)
- Elevated blood pressure (systolic >130mmHg or diastolic >85mmHg) or hypertensive drug treatment
- T2DM - fasting c-peptide of >900 pmol/L
- insulin dependent >1 year
Who cannot join
- eGFR < 60
- Abnormal alb/cr ratio >2.9
- Cigarette, cigar or pipe smoking; Occasional cannabis smoking is allowable, but not recommended
- Significant peripheral vascular disease that would prevent pancreas from safely being implanted (this is assessed as part of SOC pancreas transplant workup)
- Previous bariatric surgery
- Presence of any other condition that could compromise the patient's ability to safely undergo, or benefit from SG procedure.
- Known BK nephropathy or significant vascular damage to the kidney graft
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to evaluate the effectiveness of sleeve gastrectomy combined with pancreas after kidney (PAK) transplantation as a means of achieving normoglycemia, insulin independence, reduced insulin resistance, and kidney graft function preservation in the T2DM population. in the first year post pancreas after kidney transplant. Safety and efficacy data will be collected from the time of enrollment until participants reach 1 year post PAK transplant. Data will be compared to historical data from TGH's renal and pancreas transplant programs.
Read the detailed description
Diabetes is the leading cause of renal dysfunction and failure in Canada. Many patients will require dialysis and some with qualify for and receive a renal transplant. While a renal transplant can restore kidney function in diabetics, it does not address the underlying cause of the kidney disease. Patients remain at high risk of future morbidity from diabetes, including cardiovascular disease, retinopathy, neuropathy, and damage to the new graft. Notably, hyperglycemia is the largest risk factor to the renal bed. Good control of blood glucose levels is essential to minimize these effects but is not easily achieved or maintained.
Pancreas transplantation eliminates the use of exogenous insulin and normalizes glucose levels in the blood. Patients with Type I diabetes are routinely offered Pancreas transplant -either Pancreas After Kidney (PAK) or Simultaneous -pancreas-kidney (SPK). In rare circumstances, patients can also receive a pancreas alone (PTA). At UHN, the investigators have offered SPK transplants to select patients with type II DM who are within weight criteria (BMI <30), but the investigators do not routinely offer PAK transplants to patients with DMII as these patients are overweight and suffering from insulin resistance. Patients with DMII may not be able to achieve normoglycemia and may continue to require exogenous insulin supplementation, after PAK alone.
Weight loss in severely overweight individuals with DMII is known to improve insulin sensitivity. The majority of patients with DM II are overweight and have associated metabolic syndrome. Obesity and metabolic syndrome are themselves major risk factors for poor long-term outcomes in kidney transplantation. Weight loss can lead to improvements in all metabolic syndrome diagnostic criteria, however, it can be difficult to achieve significant and sustained weight loss in the context of insulin resistance associated with DM II. Patients who have already received a kidney transplant have the added metabolic side effects of immunosuppressive medications.
To ensure excellent long-term outcomes with kidney transplantation, it is critically important to investigate strategies to minimize obesity, control diabetes, and improve metabolic and cardiovascular risk factors. Weight loss can be achieved through dieting and exercise, but most patients who diet regain their former weight or gain additional weight. Sleeve gastrectomy (SG) is an aggressive but well-tolerated treatment for obesity which can lessen the risk factors associated with metabolic syndrome and associated poor transplant outcomes.
The investigators hypothesize that combining SG and PAK in patients with DM II who have previously undergone renal transplant will result in improvement of glycemic control, metabolic syndrome criteria, preserved/improved renal graft function and be well tolerated.
This study will investigate the safety and efficacy of SG prior to PAK (staggered approach) compared to simultaneous SG and PAK (combined approach). Safety and efficacy data will be compared to historical data from TGH's renal and pancreas transplant programs. Controls will consist of DMII patients having undergone kidney transplant only, and DMII patients having undergone SPK.
- Conditions
- Diabetes Mellitus, Type 2, Overweight
- Being tested
- Sleeve Gastrectomy AND Pancreas after Kidney Transplantation (Staggered Approach), Combined Sleeve Gastrectomy and Pancreas transplantation
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve Gastrectomy AND Pancreas after Kidney Transplantation (Staggered Approach)Procedure or surgery
Participants will undergo sleeve gastrectomy a minimum of 3 months prior to Pancreas Transplant. SG will be performed using the standard technique.
Pancreas transplant will be performed as per standard procedure.
Combined Sleeve Gastrectomy and Pancreas transplantationProcedure or surgery
Simultaneous SG and pancreas transplantation
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Staggered Approach | Experimental | The first 10 participants enrolled will undergo Sleeve Gastrectomy a minimum of 3 months prior to Pancreas Transplant. Receives: Procedure: Sleeve Gastrectomy AND Pancreas after Kidney Transplantation (Staggered Approach) |
| Group 2: Combined Approach | Experimental | Eligible participants will undergo SG and pancreas transplantation simultaneously Receives: Procedure: Combined Sleeve Gastrectomy and Pancreas transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients achieving normoglycemia
The primary study endpoint will be the proportion of patients who achieve normoglycemia (as defined by HbA1c <6%) by Month 12 post-PAK. This will be compared to the proportion of patients among the historical controls who achieve normoglycemia through medical treatment alone and have undergone kidney transplant alone or simultaneous pancreas-kidney transplantation.
Measured: month 12
Secondary outcomes (9)
Change in body weight (kg) from baseline to post-SG (group 1); baseline to post-Pancreas Tx M3 (group 2)
Change in body weight (kg) from baseline to post-SG (group 1); baseline to post-Pancreas Tx M3 (group 2)
Measured: month 3
Change in body weight (kg) from baseline to post-PAK
Change in body weight (kg) from baseline to post-PAK
Measured: month 12
Change in HbA1c levels
Change in HbA1c levels
Measured: month 12
Body mass index (BMI)
Body mass index (BMI)
Measured: month 12
Waist circumference
Waist circumference
Measured: month 12
Change in renal graft function post-PAK
Change in renal graft function measured by creatinine/urea and Alb/Creatinine ratio
Measured: months 3,6, 9 and 12
HbA1c levels post-SG
HbA1c levels post-SG (group 1)
Measured: month 3
HbA1c levels post-PAK
HbA1c levels post-PAK
Measured: months 3,6, 9 and 12
Proportion of participants with morbid obesity post PAK
Proportion of participants with morbid obesity (defined as BMI > 35) post PAK
Measured: month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start23 Sep 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
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 Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The first phase of the study will assign participants (n=10) to undergo Sleeve Gastrectomy (SG) prior to PAK. 3 months post-SG, patients will be activated on the pancreas transplant waitlist. If outcomes are favourable, the study may move to phase II (single group, n=10), which would investigate a combined surgery (simultaneous SG and pancreas transplantation).
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trevor Reichman, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576116
- Sponsor's protocol ID
- 21-5927
- Acronym
- ComB-PAK
- Status last verified
- Oct 2022
- First submitted
- 7 Oct 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
AlEnazi NA, Ahmad KS, Elsamahy IA, Essa MS. Feasibility and impact of laparoscopic sleeve gastrectomy after renal transplantation on comorbidities, graft function and quality of life. BMC Surg. 2021 May 4;21(1):235. doi: 10.1186/s12893-021-01138-x.
PubMed 33947375Viscido G, Gorodner V, Signorini FJ, Campazzo M, Navarro L, Obeide LR, Moser F. Sleeve Gastrectomy after Renal Transplantation. Obes Surg. 2018 Jun;28(6):1587-1594. doi: 10.1007/s11695-017-3056-0.
PubMed 29294221
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Bariatric Surgery and Pancreas After Kidney Transplantation for Type II Diabetics
- ClinicalTrials.gov ID
- NCT05576116
- Acronym / sponsor ID
- ComB-PAK / 21-5927
- Conditions
- Diabetes Mellitus, Type 2, Overweight
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 12 Oct 2022 (actual)
- 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 goal of this clinical trial is to evaluate the effectiveness of sleeve gastrectomy combined with pancreas after kidney (PAK) transplantation as a means of achieving normoglycemia, insulin independence, reduced insulin resistance, and kidney graft function preservation in the T2DM population. in the first year post pancreas after kidney transplant. Safety and efficacy data will be collected from the time of enrollment until participants reach 1 year post PAK transplant. Data will be compared to historical data from TGH's renal and pancreas transplant programs.
Detailed description
Diabetes is the leading cause of renal dysfunction and failure in Canada. Many patients will require dialysis and some with qualify for and receive a renal transplant. While a renal transplant can restore kidney function in diabetics, it does not address the underlying cause of the kidney disease. Patients remain at high risk of future morbidity from diabetes, including cardiovascular disease, retinopathy, neuropathy, and damage to the new graft. Notably, hyperglycemia is the largest risk factor to the renal bed. Good control of blood glucose levels is essential to minimize these effects but is not easily achieved or maintained.
Pancreas transplantation eliminates the use of exogenous insulin and normalizes glucose levels in the blood. Patients with Type I diabetes are routinely offered Pancreas transplant -either Pancreas After Kidney (PAK) or Simultaneous -pancreas-kidney (SPK). In rare circumstances, patients can also receive a pancreas alone (PTA). At UHN, the investigators have offered SPK transplants to select patients with type II DM who are within weight criteria (BMI <30), but the investigators do not routinely offer PAK transplants to patients with DMII as these patients are overweight and suffering from insulin resistance. Patients with DMII may not be able to achieve normoglycemia and may continue to require exogenous insulin supplementation, after PAK alone.
Weight loss in severely overweight individuals with DMII is known to improve insulin sensitivity. The majority of patients with DM II are overweight and have associated metabolic syndrome. Obesity and metabolic syndrome are themselves major risk factors for poor long-term outcomes in kidney transplantation. Weight loss can lead to improvements in all metabolic syndrome diagnostic criteria, however, it can be difficult to achieve significant and sustained weight loss in the context of insulin resistance associated with DM II. Patients who have already received a kidney transplant have the added metabolic side effects of immunosuppressive medications.
To ensure excellent long-term outcomes with kidney transplantation, it is critically important to investigate strategies to minimize obesity, control diabetes, and improve metabolic and cardiovascular risk factors. Weight loss can be achieved through dieting and exercise, but most patients who diet regain their former weight or gain additional weight. Sleeve gastrectomy (SG) is an aggressive but well-tolerated treatment for obesity which can lessen the risk factors associated with metabolic syndrome and associated poor transplant outcomes.
The investigators hypothesize that combining SG and PAK in patients with DM II who have previously undergone renal transplant will result in improvement of glycemic control, metabolic syndrome criteria, preserved/improved renal graft function and be well tolerated.
This study will investigate the safety and efficacy of SG prior to PAK (staggered approach) compared to simultaneous SG and PAK (combined approach). Safety and efficacy data will be compared to historical data from TGH's renal and pancreas transplant programs. Controls will consist of DMII patients having undergone kidney transplant only, and DMII patients having undergone SPK.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The first phase of the study will assign participants (n=10) to undergo Sleeve Gastrectomy (SG) prior to PAK. 3 months post-SG, patients will be activated on the pancreas transplant waitlist. If outcomes are favourable, the study may move to phase II (single group, n=10), which would investigate a combined surgery (simultaneous SG and pancreas transplantation).
| Arm | Type | Receives |
|---|---|---|
| Group 1: Staggered Approach | Experimental | Procedure: Sleeve Gastrectomy AND Pancreas after Kidney Transplantation (Staggered Approach)The first 10 participants enrolled will undergo Sleeve Gastrectomy a minimum of 3 months prior to Pancreas Transplant. |
| Group 2: Combined Approach | Experimental | Procedure: Combined Sleeve Gastrectomy and Pancreas transplantationEligible participants will undergo SG and pancreas transplantation simultaneously |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Willing and able to provide informed consent
- Females must be post-menopausal, surgically sterile or practicing adequate birth control for the duration of the study period
- Recipient of a kidney graft (either live or deceased donor) due to diabetic nephropathy
- Minimum 6 months post-Kidney transplantation surgery
- BMI >30
Key exclusion criteria (7 listed)
- eGFR < 60
- Abnormal alb/cr ratio >2.9
- Cigarette, cigar or pipe smoking; Occasional cannabis smoking is allowable, but not recommended
- Significant peripheral vascular disease that would prevent pancreas from safely being implanted (this is assessed as part of SOC pancreas transplant workup)
- Previous bariatric surgery
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 |
|---|---|---|
| Sleeve Gastrectomy AND Pancreas after Kidney Transplantation (Staggered Approach)Participants will undergo sleeve gastrectomy a minimum of 3 months prior to Pancreas Transplant. SG will be performed using the standard technique. Pancreas transplant will be performed as per standard procedure. | Procedure or surgery | Group 1: Staggered Approach |
| Combined Sleeve Gastrectomy and Pancreas transplantationSimultaneous SG and pancreas transplantation | Procedure or surgery | Group 2: Combined Approach |
Primary outcome
Patients achieving normoglycemia
Time frame: month 12
The primary study endpoint will be the proportion of patients who achieve normoglycemia (as defined by HbA1c <6%) by Month 12 post-PAK. This will be compared to the proportion of patients among the historical controls who achieve normoglycemia through medical treatment alone and have undergone kidney transplant alone or simultaneous pancreas-kidney transplantation.
9 secondary outcomes
Change in body weight (kg) from baseline to post-SG (group 1); baseline to post-Pancreas Tx M3 (group 2)
Time frame: month 3
Change in body weight (kg) from baseline to post-PAK
Time frame: month 12
Change in HbA1c levels
Time frame: month 12
Body mass index (BMI)
Time frame: month 12
Waist circumference
Time frame: month 12
Change in renal graft function post-PAK
Time frame: months 3,6, 9 and 12
HbA1c levels post-SG
Time frame: month 3
HbA1c levels post-PAK
Time frame: months 3,6, 9 and 12
Proportion of participants with morbid obesity post PAK
Time frame: month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Background: PubMed 33947375AlEnazi NA, Ahmad KS, Elsamahy IA, Essa MS. Feasibility and impact of laparoscopic sleeve gastrectomy after renal transplantation on comorbidities, graft function and quality of life. BMC Surg. 2021 May 4;21(1):235. doi: 10.1186/s12893-021-01138-x.
- Background: PubMed 29294221Viscido G, Gorodner V, Signorini FJ, Campazzo M, Navarro L, Obeide LR, Moser F. Sleeve Gastrectomy after Renal Transplantation. Obes Surg. 2018 Jun;28(6):1587-1594. doi: 10.1007/s11695-017-3056-0.
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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.
Trevor Reichman principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleeve Gastrectomy AND Pancreas after Kidney Transplantation (Staggered Approach) and Combined Sleeve Gastrectomy and Pancreas transplantation in people with Diabetes Mellitus, Type 2 and Overweight, run by University Health Network, Toronto at 1 site in Canada.
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 12 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: status not confirmed, as of the sponsor's last update on 24 Oct 2022. 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 Canada. 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?
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?
Patients achieving normoglycemia (time frame: month 12). 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 NCT05576116, 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 24 Oct 2022.