Does Islet Transplantation Eliminate Hypoglycemia?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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Low blood sugar (hypoglycemia) is a recurrent problem for many people with diabetes. Successful transplantation of clusters (islets) of normal cells, that include those which produce the sugar-lowering hormone insulin, from the pancreas of a person who did not have diabetes into a person with diabetes should eliminate high blood sugar levels. We wish to determine if it will also eliminate low blood sugar. To do so we will give insulin to lower the blood sugar, measure the levels of the hormones that normally raise blood sugar levels (e.g., glucagon and epinephrine) and then stop the insulin and see if blood sugar levels return to normal. Because we anticipate that the transplanted islets will produce insulin, but not glucagon, this study may also tell us if regulated insulin production alone can prevent hypoglycemia in humans.

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Pancreatic Islet Transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Clinically stable, insulin dependent islet transplant recipients and matched nondiabetic healthy controls

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Central Contacts

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Philip E. Cryer, M.D.

Role: CONTACT

Phone: 1-314-362-7635

Email: [email protected]

Other Identifiers

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M01RR000036

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCRR-M01RR00036-0746

Identifier Type: -

Identifier Source: org_study_id