Islet Transplantation in Type 1 Diabetic Recipients of Kidney Transplants

NCT00288977 | Completed

• 1 other identifier: 2001P001702
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study hypothesis is that we can reproduce results of islet transplantation in type one diabetics in patients with a kidney transplant.

Conditions

Diabetes; Kidney Transplantation

Keywords

Diabetes; Islet Transplantation

Outcome Measures

Primary Outcomes (1)

• independence from insulin injections with adequate control of blood glucose in subjects with Type 1 diabetes at one year post final transplant

  one year post final islet cell transplant

Study Arms (1)

islet cell transplant

EXPERIMENTAL

Procedure: Islet Infusion

Interventions

Islet Infusion PROCEDURE

islet cell transplant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrolling subjects must have Type 1 diabetes mellitus for more than 5 years, complicated by renal failure requiring a kidney transplant. The complicating situations are:
• Reduced awareness of hypoglycemia,
• Metabolic lability/instability,
• Despite efforts at optimal glucose control, progressive secondary complications of diabetes as defined by:
• i) Retinopathy- ii) Nephropathy- or
• iii) Neuropathy-

You may not qualify if:

• Severe co-existing cardiac disease, characterized by any one of these conditions:
• recent myocardial infarction (within past 6 months), or
• angiographic evidence of non-correctable coronary artery disease, or
• evidence of ischemia on functional cardiac exam (•
• Active alcohol or substance abuse-includes cigarette smoking (
• Failure to fulfill major work, school, or home responsibilities;
• Drinking in situations that are physically dangerous, such as while driving a car or operating machinery;
• Recurring alcohol-related legal problems, such as being arrested for driving under the influence of alcohol or for physically hurting someone while drunk;
• Continued drinking despite having ongoing relationship problems that are caused or worsened by the effects of alcohol.
• Psychiatric disorder making the subject not a suitable candidate for transplantation,
• History of non-adherence to prescribed regimens
• Active infection including hepatitis C, hepatitis B, HIV, or TB (or under treatment for suspected TB)
• Any history of malignancy except squamous or basal skin cancer
• BMI \> 26 kg/m2 or body weight \> 70 kg for females and \> 75kg for males at the screening visit. (An allowance for weight gain of up to +2 kg body weight is permitted between the screening visit and actual transplant. No transplant can be given to a female subject weighing \> 72 kg or a male subject weighing \> 77kg on the day of transplant. See Section 5.1 for minimum islet equivalent infusion requirements per recipient body weight.)
• C-peptide response to arginine stimulation (5 gm I.V.) (any C-peptide ≥ 0.3 ng/mL at 2, 3, 4, 5, 7 and 10 min post infusion)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Joslin Diabetes Center: collaborator

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Martha Pavlakis, MD

  Beth Israel Deaconess Medical Center, Joslin Diabetes Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: February 7, 2006
• First Posted: February 9, 2006
• Study Start: September 1, 2000
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: March 16, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share