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Clinical Trials/NCT00812578
NCT00812578CompletedPhase 2

Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes - a Randomized Controlled Trial

University of Aarhus1 site in 1 country16 target enrollmentStarted: December 2008Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
16
Locations
1
Primary Endpoint
Insulin secretion and insulin resistance
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of the study is to examine the effect on metabolic parameters after 12 weeks of treatment with high dose vitamin D in patients with type 2 diabetes and vitamin D insufficiency.

Detailed Description

There is increasing evidence that vitamin D affects the risk of diabetes. The role of vitamin D in type 2 diabetes is suggested by cross sectional studies, where an inverse association between vitamin D status and the development of type 2 diabetes has been found. Moreover supplementation with calcium and vitamin D may attenuate increases in glycemia and insulin resistance in healthy older adults with IFG. However further research is needed to confirm these findings and to determine possible mechanisms of the preventive effect from vitamin D against diabetes. The aim of this study is to examine the effect on metabolic parameters such as glycemic control, lipid status, inflammatory markers, insulin resistance and insulin secretion in patients with type 2 diabetes and vitamin D insufficiency before and after a 12-week period of treatment with high doses of vitamin D.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Informed consent
  • •Type 2 diabetes
  • •Patients of Danish extraction
  • •Vitamin D insufficiency (1,25OHvitD < 50 nmol/l)

Exclusion Criteria

  • •Nephropathy (Urea > 12 mmol/l)
  • •S-calcium > 2,52 mmol/L
  • •Primary hyperparathyroidism
  • •Serious disease
  • •Malabsorption
  • •Sarcoidosis
  • •Pregnancy

Arms & Interventions

Cholecalciferol

Active Comparator

Intervention: Cholecalciferol (Drug)

Placebo pill

Placebo Comparator

Intervention: Cholecalciferol (Drug)

Outcomes

Primary Outcomes

Insulin secretion and insulin resistance

Time Frame: 6 hours

Secondary Outcomes

  • Glycemic control, lipid status, inflammatory markers, BMD(2 months)

Investigators

Sponsor Class
Other

Study Sites (1)

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