Combined Bariatric Surgery and Pancreas After Kidney Transplantation for Type II Diabetics

NCT05576116 | Enrolling By Invitation DMC

• 1 other identifier: 21-5927
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabetes Mellitus, Type 2; Overweight

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  month 3

• Change in body weight (kg) from baseline to post-PAK

  month 12

• Change in HbA1c levels

  month 12

• Body mass index (BMI)

  month 12

• Waist circumference

  month 12

Study Arms (2)

Group 1: Staggered Approach

EXPERIMENTAL

The first 10 participants enrolled will undergo Sleeve Gastrectomy a minimum of 3 months prior to Pancreas Transplant.

Procedure: Sleeve Gastrectomy AND Pancreas after Kidney Transplantation (Staggered Approach)

Group 2: Combined Approach

EXPERIMENTAL

Eligible participants will undergo SG and pancreas transplantation simultaneously

Procedure: Combined Sleeve Gastrectomy and Pancreas transplantation

Interventions

Sleeve Gastrectomy AND Pancreas after Kidney Transplantation (Staggered Approach) PROCEDURE

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.

Group 1: Staggered Approach

Combined Sleeve Gastrectomy and Pancreas transplantation PROCEDURE

Simultaneous SG and pancreas transplantation

Group 2: Combined Approach

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

Related Publications (2)

• 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.

  PMID: 33947375 BACKGROUND

• Viscido 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.

  PMID: 29294221 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight

Interventions

Pancreas Transplantation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Officials

• Trevor Reichman

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 12, 2022
• Study Start: September 23, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 24, 2022

Record last verified: 2022-10

Locations

CA (1)