A Pilot Feasibility Study of Fibroblast Calcium and Glucoregulation in Health and Disease
A Pilot Feasibility Study of Fibroblast Calcium and Glucoregulation in Health
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Contacts et emplacements
Lieux d'étude
-
-
Kentucky
-
Lexington, Kentucky, États-Unis, 40536
- University of Kentucky Center for Clinical and Translational Science
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Are peak (nM) calcium responses to bradykinin enhanced along the continuum of disease in skin fibroblasts from the 4 patient groups?
Délai: Three years
|
All participants groups will be compared statistically to the lean patient group.
|
Three years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Are glucose utilization rates (a.u./min) measured in skin fibroblasts from the 4 patient groups different with disease progression?
Délai: Three years
|
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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
What component of peripheral metabolic dysregulation (HbA1c (%), adiponectin (ug/mL), cholesterol (mg/dL)) is associated with changes in calcium responses (nM) in skin fibroblasts?
Délai: Three years
|
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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Olivier Thibault, PhD, University of Kentucky
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 13-0571-F1V
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .