- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Contacten en locaties
Studie Locaties
-
-
Kentucky
-
Lexington, Kentucky, Verenigde Staten, 40536
- University of Kentucky Center for Clinical and Translational Science
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Are peak (nM) calcium responses to bradykinin enhanced along the continuum of disease in skin fibroblasts from the 4 patient groups?
Tijdsspanne: Three years
|
All participants groups will be compared statistically to the lean patient group.
|
Three years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Are glucose utilization rates (a.u./min) measured in skin fibroblasts from the 4 patient groups different with disease progression?
Tijdsspanne: 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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
What component of peripheral metabolic dysregulation (HbA1c (%), adiponectin (ug/mL), cholesterol (mg/dL)) is associated with changes in calcium responses (nM) in skin fibroblasts?
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie directeur: Olivier Thibault, PhD, University of Kentucky
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 13-0571-F1V
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Type 2 diabetes
-
University of Trás-os-Montes and Alto DouroVoltooidDiabetes mellitus type 2 | Diabetesgerelateerde complicatiesPortugal
-
Chengdu Brilliant Pharmaceutical Co., Ltd.Nog niet aan het wervenDiabetes mellitus type 2
-
Endogenex, Inc.Nog niet aan het wervenDiabetes mellitus, type 2 | Suikerziekte | Diabetes mellitus type 2 | Type 2 diabetes | Type 2 diabetes
-
Jeil Pharmaceutical Co., Ltd.Nog niet aan het wervenDiabetes mellitus type 2Korea, republiek van
-
Nanjing First Hospital, Nanjing Medical UniversityWervingDiabetes mellitus type 2China
-
Nanjing First Hospital, Nanjing Medical UniversityWerving
-
Xiangya Hospital of Central South UniversityWerving
-
Sun Yat-sen UniversityGuangdong Provincial Hospital of Traditional Chinese Medicine; The Third Affiliated... en andere medewerkersWerving
-
University of Alabama at BirminghamVoltooidDiabetes mellitus type 2Verenigde Staten
-
BayerActief, niet wervend