NCT01917669

A Pilot Feasibility Study of Fibroblast Calcium and Glucoregulation in Health and Disease

A Pilot Feasibility Study of Fibroblast Calcium and Glucoregulation in Health

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: University of Kentucky · Academic / Other
• Sex: All
• Age: 40 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research is to better understand how calcium and glucose may play a role in people developing diabetes. By doing this study, the investigator hopes to learn whether abnormal calcium and glucose responses in skin biopsies from healthy patients and patients with Type 2 diabetes can identify and predict patients at greatest risk for later complications.

Detailed description

The overall goal of this proposal is to establish a pathophysiological index of a patient's status through imaging of calcium and glucose in skin fibroblasts. The investigator will obtain skin samples from patients in the Barnstable Brown Obesity and Diabetes Center at the University of Kentucky to test the hypothesis that calcium and glucose dysregulation are present in fibroblasts from patients with Type 2 diabetes, and are exaggerated in more difficult-to-treat patients or those with poor glucose control. The innovation of the project focuses on results that can potentially lead to earlier treatment for patients with diabetes and thereby reduce the risk for long-term complications. Three levels of analyses will be conducted to assess the relationship between Ca2+ and glucose homeostasis in four patient groups (lean non-diabetics, obese non-diabetics, Type 2 Diabetics with good glucose control, and Type 2 Diabetics with poor control. Participants will be required to attend only one study visit that will last approximately 2-3 hours. During the study subject will undergo the following: 1. Collection of two 4 ml tubes of blood for adiponectin analysis, 2. A skin biopsy, 3. Collection and review of medical history and current/past medication use 4. Collection of demographic information, 5. Height and weight measurement 6. Body mass index evaluation, 7. Vital signs assessment (blood pressure, pulse). Follow-up for all enrolled patients will occur on a yearly basis through a phone interview. The punch biopsy will be performed under local anesthesia.

Conditions

• Type 2 Diabetes

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2013-08-07
• Last updated: 2016-10-25

Locations

1 site across 1 country: United States