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Clinical Trial Details

Trial ID: L4626
Source ID: NCT01709123
Associated Drug: Chromium Niacinate
Title: Effects of Micronutrient (Chromium) Supplementation on Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01709123/results
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: chromium niacinate|DRUG: placebo
Outcome Measures: Primary: Blood Glucose Level, Measuring levels of glycemia (fasting glucose) in blood of patients in the placebo group and the chromium supplement group., Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.|Blood Glucose Levels, Measuring levels of glycemia (HbA1c) in blood patients in the placebo group and the chromium supplement group., Assessed for 16 weeks with five measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks). 16 weeks reported. | Secondary: Lipid Levels, Measuring levels of TG (triglycerides), LDL and HDL-cholesterol in blood of patients in the placebo group and the chromium supplement group., Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.|Blood Levels of Cytokines/Inflammatory Biomarkers, Measuring levels of reactive oxygen species (ROS) in blood of patients in the placebo group and chromium supplement group., Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.|Blood Levels of Cytokines/Inflammatory Biomarkers, Measuring levels of Interleukin-6 (IL-6) in blood of patients in the placebo group and chromium supplement group., Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.|Blood Levels of Cytokines/Inflammatory Biomarkers, Measuring levels of C reactive protein (CRP) in blood of patients in the placebo group and chromium supplement group., Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.|Blood Levels of Cytokines/Inflammatory Biomarkers, Measuring levels of Leptin in blood of patients in the placebo group and chromium supplement group., Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.
Sponsor/Collaborators: Sponsor: Louisiana State University Health Sciences Center Shreveport | Collaborators: National Institutes of Health (NIH)|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Gender: ALL
Age: CHILD, ADULT
Phases:
Enrollment: 62
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2007-08
Completion Date: 2013-09
Results First Posted: 2022-06-30
Last Update Posted: 2022-06-30
Locations: Louisiana State University Health Sciences Center in Shreveport, Shreveport, Louisiana, 71130, United States
URL: https://clinicaltrials.gov/show/NCT01709123