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

Type 2 Diabetes Clinical Trial

Official title:

A Pilot Feasibility Study of Fibroblast Calcium and Glucoregulation in Health

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01917669
• Other study ID #: 13-0571-F1V
• Status: Withdrawn
• Phase: N/A
• First received: July 31, 2013
• Last updated: October 24, 2016
• Start date: October 2013
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 55 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Type 2 Diabetes

Locations

Country	Name	City	State
United States	University of Kentucky Center for Clinical and Translational Science	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Kentucky	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No