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Vitamin D for Established Type 2 Diabetes (DDM2)

This study is currently recruiting participants.
Verified April 2013 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT01736865
First received: November 15, 2012
Last updated: April 30, 2013
Last verified: April 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes
 Drug: Cholecalciferol
Drug: Placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Disposition index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Disposition index by the insulin secretion sensitivity index-2 (ISSI-2)


Secondary Outcome Measures:
  • Change in glycemia [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Change in diabetes medications [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Variability of response to vitamin D supplementation in subgroups. [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Variability of response to vitamin D supplementation in subgroups defined by baseline characteristics: (1) race; (3) 25OHD concentration; (3) diabetes treatment.

  • Effect of vitamin D supplementation on blood 25-hydroxyvitaminD concentration [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Cardiovascular risk factors [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Cardiovascular risk factors defined as blood pressure, lipid profile, C-reactive protein and urine albumin excretion


Estimated Enrollment: 124
Study Start Date: December 2012
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
One placebo pill daily for 1 year
 Drug: Placebo
Active Comparator: cholecalciferol
One cholecalciferol pill daily for 1 year
 Drug: Cholecalciferol

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736865

Locations
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Paul Fuss         ddm2@tuftsmedicalcenter.org    
Principal Investigator: Anastassios Pittas, MD MS            
United States, Ohio
Cincinnati VA Medical Center Not yet recruiting
Cincinnati, Ohio, United States
Principal Investigator: David D'Alessio, MD            
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

No publications provided

Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT01736865     History of Changes
Other Study ID Numbers: DK76092-06
Study First Received: November 15, 2012
Last Updated: April 30, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cholecalciferol
 Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 19, 2013