Ketosis, Vascular Inflammation, and Its Therapy (Chromium Supplementation) in Diabetic Patients
8 Years
21 Years
Both
Diabetes Mellitus, Type 1
Trial Information
Ketosis, Vascular Inflammation, and Its Therapy (Chromium Supplementation) in Diabetic Patients
Inclusion Criteria:
- Clinical diagnosis of Type 1 diabetes mellitus
- Participants between the ages of 8 and 21
Exclusion Criteria:
- Subjects with sickle cell disease, renal or liver disease
- Serum positive pregnancy test or breastfeeding
- Participants unwilling/unable to take supplements in pill form
- Participants taking prescription medication or supplements
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Blood levels of glycemia
Outcome Description:
Fasting glucose levels and HbA1C
Outcome Time Frame:
Measured at each clinical visit blood draw, starting with the first visit and ending with the fifth. Each visit is scheduled 4 weeks apart, for a total time of 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks)
Safety Issue:
No
Principal Investigator
Sushil K Jain, Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Louisiana State University Health Sciences Center in Shreveport
Authority:
United States: Institutional Review Board
Study ID:
H-08-028
NCT ID:
NCT01709123
Start Date:
August 2007
Completion Date:
September 2013
Related Keywords:
- Diabetes Mellitus, Type 1
- Diabetes Mellitus, Juvenile Onset
- Cardiovascular Diseases
- Hyperglycemia
- Hyperketonemia
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
Name | Location |
|---|---|
| Louisiana State University Health Sciences Center in Shreveport | Shreveport, Louisiana 71130 |
