Vitamin D for Established Type 2 Diabetes (DDM2)

Type 2 Diabetes Clinical Trial

— DDM2  

Official title:

Vitamin D for Established Type 2 Diabetes (DDM2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01736865
• Other study ID #: DK76092-06
• Secondary ID: R01DK076092
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 2012
• Est. completion date: August 2015

Study information

• Verified date: March 2020
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study in adults with established type 2 diabetes will test whether daily vitamin D supplementation affects how the body processes glucose (sugar).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

• Established type 2 diabetes, defined by one of the following two criteria:

• Age = 25 years and = 75 years

• BMI: 23 to 40 kg/m2 inclusive

• Provision of signed and dated written informed consent prior to any study procedures.

Major Exclusion Criteria

• "Severe" diabetes defined by one of the following criteria:

• - (a) Symptoms of hyperglycemia;

• - (b) Screening HbA1c = 7.5 [may indicate potential for rapid progression during the trial necessitating need to amplify diabetes-specific pharmacotherapy]

• History of nephrolithiasis or hypercalcemia

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Cholecalciferol

• Placebo

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts
United States	Cincinnati VA Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hemoglobin A1c		12 months
Other	Change in Diabetes Medications		6 and 12 months
Other	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
Other	Effect of Vitamin D Supplementation on Blood 25-hydroxyvitaminD Concentration		12 months
Other	Cardiovascular Risk Factors	Cardiovascular risk factors defined as blood pressure, lipid profile, C-reactive protein and urine albumin excretion	6 and 12 months
Other	Effect of Vitamin D Supplementation on Plasma Concentrations of Surrogate Biomarkers of Cholesterol Absorption (Campesterol and ß-sitosterol) and Endogenous Synthesis (Lathosterol and Desmosterol)		6 months
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