Assessment of Insulin Production From Native Pancreas in Patients With Pancreas Transplants

NCT00246844 | Completed

• 2 other identifiers: 06001906-DK-0019
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine whether insulin-producing cells in the pancreas (beta cells) can recover in patients with type 1 diabetes who have had a pancreas transplant. In type 1 diabetes, the body's immune system destroys the beta cells. Patients are treated with insulin shots or a pancreas transplant to control their blood sugar. Some experiments suggest that the pancreas may have the capacity to recover some of its insulin-producing capacity, but that ability is negated by factors such as the continuing immune attack and erratic blood sugar levels in patients. Patients who have had a pancreas transplant may be in a unique situation to allow their own pancreas to regrow beta cells for two reasons: 1) the medicines they take to prevent rejection of the transplanted pancreas weaken their immune system; and 2) they have near-normal blood sugar levels because of their functioning transplanted pancreas. This study will test this hypothesis by sampling blood from patients' hepatic vein, which drains the liver and native pancreas and from their iliac vein, which drains the transplanted pancreas. This will determine whether insulin is coming from the transplanted pancreas (iliac vein) or the liver and native pancreas (hepatic vein). Patients 18 years of age and older who have had stable pancreatic transplant function for more than 5 years may be eligible for this study. Candidates are screened with a medical history and physical examination. Participants are admitted to the hospital for 2 days for a full medical examination, blood tests and procedures to determine insulin production. The procedures will include the placement of catheters in the neck and groin for blood sampling. Participants will be closely monitored after the procedures and discharged home if there are no complications.

Conditions

Long-Functioning Pancreas Allografts; Pancreas Transplant

Keywords

Transplant; Diabetes; C-Peptide; B Cell; Immunosuppression; Type 1 Diabetes; Pancreas Transplant

Eligibility Criteria

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

You may qualify if:

• Patients will be included if:
• Age greater than or equal to 18
• GFR greater than 50 ml/min/1.73 m2
• History consistent with T1DM prior to pancreas transplant

You may not qualify if:

• Liver dysfunction (elevated liver enzymes, clinical evidence of portal hypertension)
• coagulopathy (elevated INR or Partial Thromboplastin Time)
• History of repeated instrumentation/cannulation in the jugular or femoral vessels
• Dye allergy
• Pregnancy
• Known vascular anomalies
• Anemia with Hgb less than 10

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

• Foulis AK, Liddle CN, Farquharson MA, Richmond JA, Weir RS. The histopathology of the pancreas in type 1 (insulin-dependent) diabetes mellitus: a 25-year review of deaths in patients under 20 years of age in the United Kingdom. Diabetologia. 1986 May;29(5):267-74. doi: 10.1007/BF00452061.

  PMID: 3522324 BACKGROUND

• Liu EH, Digon BJ 3rd, Hirshberg B, Chang R, Wood BJ, Neeman Z, Kam A, Wesley RA, Polly SM, Hofmann RM, Rother KI, Harlan DM. Pancreatic beta cell function persists in many patients with chronic type 1 diabetes, but is not dramatically improved by prolonged immunosuppression and euglycaemia from a beta cell allograft. Diabetologia. 2009 Jul;52(7):1369-80. doi: 10.1007/s00125-009-1342-7. Epub 2009 May 6.

  PMID: 19418039 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 29, 2005
• First Posted: October 31, 2005
• Study Start: October 26, 2005
• Study Completion: August 15, 2007
• Last Updated: July 2, 2017

Record last verified: 2007-08-15

Locations

US (1)