Insulin Sensitivity, Impaired Counterregulation, and Glucose Variability (BPK005)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sue Brown, University of Virginia
ClinicalTrials.gov Identifier:
NCT01439672
First received: September 20, 2011
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

This protocol will investigate physiological parameters including insulin sensitivity and counterregulatory function using a mixed meal test and induced hypoglycemia in subjects with type I diabetes.


Condition Intervention
Type 1 Diabetes Mellitus
Dietary Supplement: Mixed meal and insulin challenge

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Insulin Sensitivity, Impaired Counterregulation, and Glucose Variability

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Measure insulin sensitivity following a mixed meal.


Secondary Outcome Measures:
  • Hormonal Response to Hypoglycemia [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ]
    Measurement of counterregulatory effects measured by epinephrine response following hypoglycemia. Will also measure glucagon, growth hormone and cortisol.


Enrollment: 35
Study Start Date: August 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin Sensitivity
Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity.
Dietary Supplement: Mixed meal and insulin challenge
The subject will undergo a mixed meal and insulin challenge as follows: an insulin bolus will be administered and a mixed meal nutrition drink will be consumed over 1-5 minutes. The mixed meal nutrition drink will be selected for that individual to be most likely to raise the glucose levels by 100mg/dl and then return to baseline within a four-hour time period. The nutrition drink will selected from the following types of product lines: Boost products (Nestle Nutrition), Ensure products (Abbott Nutrition), Carnation Instant Breakfast (Nestle Nutrition) or Glucerna (Abbott Nutrition).The pre-meal insulin bolus will be calculated to bring the subject to ~100mg/dl at 1100.

Detailed Description:

The principal idea of the proposed research is: in order to be successful, closed-loop control of glucose in diabetes must adapt to individual physiologic characteristics and to the behavioral profile of each person. We propose to build a system that will use observers of patients' behavior and metabolic state and control modules that are responsible for insulin delivery and hypoglycemia prevention. In this phase of the project, we will investigate relationships of insulin sensitivity and impaired counterregulation with blood glucose variability, aiming to develop algorithmic physiology observers, which will track specific parameters of glucose variability and recurrent hypoglycemia as markers of change in a person's insulin sensitivity and counterregulatory ability.

  Eligibility

Ages Eligible for Study:   21 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type I diabetes mellitus (TIDM) (as defined by the American Diabetes Association criteria or judgment of a physician) for at least two years prior to the enrollment in the study.
  • Use of an insulin pump to treat their diabetes for at least six months prior to the study.
  • Ability to use a bolus calculator function with the current insulin pump with pre-defined parameters for glucose goal, carbohydrate ratio, and insulin sensitivity factor.
  • Age 21 - 64 years. Adults age 65 and over are likely to have medical exclusions for the follow-up Phase 2 study, which involves induced hypoglycemia.
  • Completed Phase 1 of the Institutional Review Board (IRB) #14956 "Development of a Behavioral Observer for Type 1 Diabetes Mellitus"
  • Willingness to use lispro (Humalog) insulin two days prior to and during inpatient admission.
  • Willingness to perform Self-Monitoring Blood Glucose (SMBG) 4 times per day at times before meals and bedtime.
  • Demonstration of proper mental status and cognition for completion of the study.

Exclusion Criteria:

  • Pregnancy
  • Psychiatric disorders that would interfere with study tasks (e.g. mental retardation, substance abuse)
  • History of a systemic deep tissue infection with methicillin-resistant staph aureus or Candida albicans
  • Known bleeding diathesis or dyscrasia
  • Active enrollment in another clinical trial
  • Medical condition that would make operating an insulin pump difficult (e.g. blindness, severe arthritis, extensive scar tissue at sites where devices are inserted).
  • Anemia (hematocrit <36% [females], <38% [males]),
  • Allergy or adverse reaction to lispro (Humalog) insulin
  • Conditions which may increase the risk of induced hypoglycemia such as symptomatic heart disease, congestive heart failure, history of a cerebrovascular event, atrial fibrillation, renal insufficiency (creatinine >1.5) or uncontrolled hypertension (resting blood pressure >140/90).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01439672

Locations
United States, Virginia
University of Virginia, Center for Diabetes Technology
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Sue Brown, MD University of Virginia
  More Information

No publications provided

Responsible Party: Sue Brown, Assistant Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT01439672     History of Changes
Other Study ID Numbers: 15131, R01DK085623
Study First Received: September 20, 2011
Last Updated: November 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
Type 1 Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hyperinsulinism
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014