To Evaluate if Wide Blood Sugar Fluctuations Lead to Injury of Heart Function and Heart Nerves

NCT01170832 | Completed DMC

• 1 other identifier: HUM 00036408
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This proposal will test if, in patients with type 1 diabetes, wide blood glucose fluctuations lead to the injury to heart nerves , called cardiac autonomic neuropathy (CAN), and to impaired heart contractile (pumping) function and heart failure. It will also evaluate the natural history of heart failure and enhanced cardiac risk in patients with type 1 diabetes in the current standard of diabetes care.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Heart rate (HR) Variability Studies

  Evaluation of heart rate variability and 24 hour blood pressure monitoring: electrocardiogram (ECG) and blood pressure will be recorded while resting in a lying down position and during certain controlled procedures that include deep breathing and other clinical maneuvers such as standing up and exhaling deeply.

  Three years

Secondary Outcomes (1)

• Positron Emission Tomography (PET) scan

  Test to be completed at baseline and end of study (3yrs)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Type 1 diabetics who have been diagnosed between 5-10 years and do not have any complications that are associated with Diabetes

You may not qualify if:

• Male or female between the ages 18-65, with type 1 diabetes of 5-10 years duration who are free of complications and age-and-sex-matched healthy control volunteers.
• Hemoglobin A1c greater than 7 %. (For Type 1 diabetics)
• If you are a woman of childbearing potential you must agree to use an acceptable birth control method throughout the duration of the study. The methods of birth control that you can use are: Oral contraceptives (birth control pill), IUD or a barrier method (e.g. diaphragm or condom with spermicide).
• You should have no history of any cardiovascular disease including any form of coronary artery disease, congestive heart failure, known arrhythmias (irregular heart beats), valvular disease or high blood pressure.
• If you have any pacemaker or ICD, if you have any metallic foreign body such as surgical implants or clips or foreign bodies in the eye or orbits, wearing medication patches containing foil, or any other metal in the body or if you are claustrophobic you cannot participate in this study.
• You should be free of any diabetic complications (e.g. nephropathy or kidney damage, retinopathy or eye damage), have no history of previous kidney, pancreas or cardiac transplantation, any other severe chronic illness that has neuropathy (numbness, burning or tingling) and/or neurologic disease as a recognized complication (e.g. Parkinson's disease, epilepsy), or any other serious medical conditions that may shorten life span (e.g. disabling stroke, Chronic Obstructive Pulmonary Disease).
• You should be free of any malignancy other than basal cell skin cancer.
• No history of alcohol abuse.
• You should not use any agents or drugs that interfere with the imaging techniques described below.
• You must be able to cooperate with the test protocols that are described below and be willing to sign this consent form.
• BMI \<30
• If female, must not be pregnant or nursing
• Normal blood pressure
• Normal labs-(glucose and lipids)

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University Of Michigan

Ann Arbor, Michigan, 48106, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

We will collect approximately 15 ml of whole blood for DNA sampling and storage.

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

Study Officials

• Rodica Pop-Busui, MD, Ph.D

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine/MEND

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: July 27, 2010
• Study Start: May 1, 2010
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 27, 2018

Record last verified: 2018-08

Locations

US (1)