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Comparison of Insulin Therapy in Treating Post-Transplant Diabetes

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ClinicalTrials.gov Identifier: NCT01963728
Recruitment Status : Terminated (Difficult to enroll. The blood sugar status of the two enrolled subjects was not evaluable due to multiple hospital admissions.)
First Posted : October 16, 2013
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Inova Health Care Services

Brief Summary:
To determine if the use of insulin isophane results in improved control of blood sugars compared to the use of insulin glargine in new onset diabetes after kidney, lung, or heart transplantation (NODAT).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Insulin, Isophane Drug: insulin glargine Phase 4

Detailed Description:

A large percentage of organ transplant recipients develop de novo diabetes mellitus after transplantation, also called "New Onset Diabetes After Transplant" or NODAT. The cause of the diabetes appears to be commonly used anti-rejection medications, particularly calcineurin inhibitors and glucocorticoids.

Management of glucose levels in NODAT often requires insulin therapy. Standard practice is to start long-acting insulin. However, patients with NODAT often exhibit fasting morning glucose levels that are relatively low compared to pre-lunch and pre-dinner glucose levels. This seems to make NODAT patients more susceptible to fasting, or morning, hypoglycemia on long-acting insulin analogues than non-transplant patients with type II diabetes. This phenomenon of morning hypoglycemia in NODAT often limits the up-titration of basal insulin resulting in suboptimal treatment of hyperglycemia later in the day. Because of this pattern, transplant patients may respond better to morning insulin isophane (intermediate acting) than to long-acting insulin glargine preparations.

Our trial is designed to compare morning NPH insulin (isophane insulin) with conventional therapy of basal glargine insulin on both continuous blood glucose levels and hemoglobin A1c (glycosylated hemoglobin).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Insulin Isophane (NPH) With Insulin Glargine in New Onset Diabetes After Transplant (NODAT)
Study Start Date : May 2014
Estimated Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: insulin isophane
daily dose will be titrated based on fasting morning glucose values
Drug: Insulin, Isophane
daily dosing based on fasting morning glucose levels
Other Name: human NPH

Active Comparator: insulin glargine
daily dose will be titrated based on fasting morning glucose values
Drug: insulin glargine
daily dose based on fasting morning glucose levels
Other Name: Lantus




Primary Outcome Measures :
  1. change in Hemoglobin A1C (glycosylated hemoglobin) [ Time Frame: at 3 monnths post enrollment ]
  2. change in hemoglobin A1C (glycosylated hemoglobin) [ Time Frame: at 6 months post enrollment ]

Secondary Outcome Measures :
  1. Mean blood glucose values [ Time Frame: 3 and 6 months post enrollment ]
    measured by continuous glucose monitoring for 5 days

  2. weight change [ Time Frame: 3 and 6 months post enrollment ]
  3. incidence of hypoglycemic episodes per subject [ Time Frame: from the start of enrollment to subject completion of study at 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must be followed by the Inova Fairfax Hospital transplantation program for post-transplant care
  2. Diabetes mellitus inadequately responsive to lifestyle modification and non-insulin hypoglycemic medication
  3. Need for subcutaneous insulin therapy (after discontinuation of IV insulin therapy, if it was required)
  4. Ability to read consent form and give consent in English.

Exclusion Criteria:

  1. Use of insulin or non-insulin hypoglycemic medication before transplantation
  2. Cystic fibrosis patients
  3. Age < 18 years of age
  4. Pregnancy
  5. Non-English speaking subjects

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01963728


Locations
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United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
Inova Health Care Services
Investigators
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Principal Investigator: Peter Ross, MD Inova Healthcare Services

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Responsible Party: Inova Health Care Services
ClinicalTrials.gov Identifier: NCT01963728     History of Changes
Other Study ID Numbers: Inova NODAT-001
First Posted: October 16, 2013    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015
Keywords provided by Inova Health Care Services:
post-transplant
diabetes mellitus
renal transplant
kidney transplant
lung transplant
heart transplant
insulin
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs