Insulin Sensitivity, Impaired Counterregulation, and Glucose Variability

NCT01439672 | Completed Results

• 2 other identifiers: 15131R01DK085623
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Insulin Sensitivity

  Measure insulin sensitivity following a mixed meal across admissions. Insulin sensitivity was measured based on the minimal model of glucose kinetics using plasma glucose and insulin obtained frequently (approximately every 5-15 minutes) in response to mixed meal challenge.

  24 hours

Study Arms (1)

Insulin Sensitivity

EXPERIMENTAL

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

Interventions

Mixed meal and insulin challenge DIETARY_SUPPLEMENT

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.

Insulin Sensitivity

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

University of Virginia, Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Sue Brown, MD
• Organization: University of Virginia

sab2f@virginia.edu

Study Officials

• Sue Brown, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Assistant Professor

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: September 23, 2011
• Study Start: August 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: December 6, 2016
• Results First Posted: April 14, 2015

Record last verified: 2016-10

Locations

US (1)