| Trial ID: | L3096 |
| Source ID: | NCT01736865
|
| Associated Drug: |
Cholecalciferol
|
| Title: |
Vitamin D for Established Type 2 Diabetes (DDM2)
|
| Acronym: |
DDM2
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01736865/results
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Cholecalciferol|DRUG: Placebo
|
| Outcome Measures: |
Primary: Disposition Index, Disposition index by the insulin secretion sensitivity index-2 (ISSI-2). This is an calculated value which represents the ability of a person's pancreatic beta cells to lower blood glucose. A higher number means the pancreas is better able to secrete insulin and improve glucose levels., 6 months | Secondary: Number of Participants With Change in Glycemia, Change in glycemia (categorical variable, composite outcome) defined as \[1\] a decrease in diabetes medications or \[2\] a reduction of equal to or more than 0.4 HbA1c units from baseline without increasing medications., 12 months | Other: Hemoglobin A1c, 12 months|Change in Diabetes Medications, 6 and 12 months|Variability of Response to Vitamin D Supplementation in Subgroups., Variability of response to vitamin D supplementation in subgroups defined by baseline characteristics: (1) race; (3) 25OHD concentration; (3) diabetes treatment., Baseline and 12 months|Effect of Vitamin D Supplementation on Blood 25-hydroxyvitaminD Concentration, 12 months|Cardiovascular Risk Factors, Cardiovascular risk factors defined as blood pressure, lipid profile, C-reactive protein and urine albumin excretion, 6 and 12 months|Effect of Vitamin D Supplementation on Plasma Concentrations of Surrogate Biomarkers of Cholesterol Absorption (Campesterol and β-sitosterol) and Endogenous Synthesis (Lathosterol and Desmosterol), 6 months
|
| Sponsor/Collaborators: |
Sponsor: Tufts Medical Center | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
127
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-12
|
| Completion Date: |
2015-08
|
| Results First Posted: |
2019-01-11
|
| Last Update Posted: |
2020-04-01
|
| Locations: |
Tufts Medical Center, Boston, Massachusetts, 02111, United States|Cincinnati VA Medical Center, Cincinnati, Ohio, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01736865
|
