- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
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
Contacts and Locations
Study Locations
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Kentucky
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Lexington, Kentucky, United States, 40536
- University of Kentucky Center for Clinical and Translational Science
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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?
Design Details
Cohorts and Interventions
Group / Cohort |
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Lean Non-Diabetic Group
Variables measured will also include serum analyses (HbA1c, adiponectin, cholesterol) and patient vital signs.
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Pre-diabetics
These patients are anticipated to have elevated BMI, yet not be diabetics.
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Diabetic Patients
These patients will have good glucose control.
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Diabetic patients with poor glucocontrol
These patients are anticipated to have poor glucose control.
They are usually taking insulin.
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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?
Time Frame: Three years
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All participants groups will be compared statistically to the lean patient group.
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Three years
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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?
Time Frame: Three years
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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.
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Three years
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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?
Time Frame: Three years
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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.
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Three years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Olivier Thibault, PhD, University of Kentucky
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 13-0571-F1V
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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