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

A Pilot Feasibility Study of Fibroblast Calcium and Glucoregulation in Health

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.

Study Overview

• Status: Withdrawn
• Conditions: Type 2 Diabetes

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Center for Clinical and Translational Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

We will recruit both male and female participants. The age range for this study is 40-55 years old

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Lean Non-Diabetic Group; Variables measured will also include serum analyses (HbA1c, adiponectin, cholesterol) and patient vital signs.
Pre-diabetics; These patients are anticipated to have elevated BMI, yet not be diabetics.
Diabetic Patients; These patients will have good glucose control.
Diabetic patients with poor glucocontrol; These patients are anticipated to have poor glucose control. They are usually taking insulin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Are peak (nM) calcium responses to bradykinin enhanced along the continuum of disease in skin fibroblasts from the 4 patient groups?	All participants groups will be compared statistically to the lean patient group.	Three years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Are glucose utilization rates (a.u./min) measured in skin fibroblasts from the 4 patient groups different with disease progression?	A unitless index of health status based on serum analyses (cholesterol, adiponectin, HbA1c) for each patient will be correlated with a unitless index of glucose status based on fibroblast imaging data.	Three years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
What component of peripheral metabolic dysregulation (HbA1c (%), adiponectin (ug/mL), cholesterol (mg/dL)) is associated with changes in calcium responses (nM) in skin fibroblasts?	The investigator will also focus on two groups of patients, obese-non-diabetics and diabetics with poor control, during the analysis period and prospectively follow these patients for clinical outcomes.	Three years

Collaborators and Investigators

• Sponsor: University of Kentucky
• Collaborators: American Diabetes Association
• Investigators: Study Director: Olivier Thibault, PhD, University of Kentucky

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: July 31, 2013
• First Submitted That Met QC Criteria: August 6, 2013
• First Posted (Estimate): August 7, 2013

Study Record Updates

• Last Update Posted (Estimate): October 25, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 13-0571-F1V