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

NCT ID: NCT01917669

Last Updated: 2016-10-25

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-09-30

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Lean Non-Diabetic Group

Variables measured will also include serum analyses (HbA1c, adiponectin, cholesterol) and patient vital signs.

No interventions assigned to this group

Pre-diabetics

These patients are anticipated to have elevated BMI, yet not be diabetics.

No interventions assigned to this group

Diabetic Patients

These patients will have good glucose control.

No interventions assigned to this group

Diabetic patients with poor glucocontrol

These patients are anticipated to have poor glucose control. They are usually taking insulin.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Healthy
• Type 2 Diabetes

Exclusion Criteria

• Under 40 years of age
• Over 55 years of age
• Pregnant or breastfeedig
• Will not agree to a skin biopsy
• Talking calcium channel blockers

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Diabetes Association

OTHER

Sponsor Role: collaborator

University of Kentucky

OTHER

Sponsor Role: lead

Responsible Party

Olivier Thibault, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olivier Thibault, PhD

Role: STUDY_DIRECTOR

University of Kentucky

Locations

University of Kentucky Center for Clinical and Translational Science

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

13-0571-F1V

Identifier Type: -

Identifier Source: org_study_id