Vitamin D for Established Type 2 Diabetes (DDM2)

Phase 2

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Placebo; Drug: Cholecalciferol

• Registration Number: NCT01736865
• Lead Sponsor: Tufts Medical Center

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-15
• Study First Submitted QC: 2012-11-26
• Study First Posted: 2012-11-29
• Study Start: 2012-12
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Results First Submitted: 2017-12-01
• Results First Submitted QC: 2019-01-10
• Results First Posted: 2019-01-11
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	One placebo pill daily for 1 year
cholecalciferol	Cholecalciferol	One cholecalciferol pill daily for 1 year

Primary Outcome Measures

Name	Time	Method
Disposition Index	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Change in Glycemia	12 months	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.

Trial Locations

Locations (2)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Cincinnati VA Medical Center; 🇺🇸 Cincinnati, Ohio, United States