or
forgot password

Ketosis, Vascular Inflammation, and Its Therapy (Chromium Supplementation) in Diabetic Patients


N/A
8 Years
21 Years
Open (Enrolling)
Both
Diabetes Mellitus, Type 1

Thank you

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