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Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes (ProjectD)

Primary Purpose

Type 2 Diabetes, Vitamin D Insufficiency

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Cholecalciferol
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Vitamin D insufficiency, Insulin secretion, Insulin sensitivity, Pulsatility

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Research Unit, Medical Department M, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cholecalciferol

Placebo pill

Arm Description

Outcomes

Primary Outcome Measures

Insulin secretion and insulin resistance

Secondary Outcome Measures

Glycemic control, lipid status, inflammatory markers, BMD

Full Information

First Posted
December 19, 2008
Last Updated
July 9, 2010
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Regionshospitalet Silkeborg
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1. Study Identification

Unique Protocol Identification Number
NCT00812578
Brief Title
Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes
Acronym
ProjectD
Official Title
Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Regionshospitalet Silkeborg

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Vitamin D Insufficiency
Keywords
Type 2 diabetes, Vitamin D insufficiency, Insulin secretion, Insulin sensitivity, Pulsatility

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cholecalciferol
Arm Type
Active Comparator
Arm Title
Placebo pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Intervention Description
8 tablets equivalent to 280 micrograms for 2 weeks and 4 tablets equivalent to 140 micrograms for 10 weeks
Primary Outcome Measure Information:
Title
Insulin secretion and insulin resistance
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Glycemic control, lipid status, inflammatory markers, BMD
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lotte Oeskov, MD
Organizational Affiliation
Medical Department, Silkeborg Hospital, Falkevej 1-3, 8600 Silkeborg, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Research Unit, Medical Department M, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
25044176
Citation
Kampmann U, Mosekilde L, Juhl C, Moller N, Christensen B, Rejnmark L, Wamberg L, Orskov L. Effects of 12 weeks high dose vitamin D3 treatment on insulin sensitivity, beta cell function, and metabolic markers in patients with type 2 diabetes and vitamin D insufficiency - a double-blind, randomized, placebo-controlled trial. Metabolism. 2014 Sep;63(9):1115-24. doi: 10.1016/j.metabol.2014.06.008. Epub 2014 Jun 19.
Results Reference
derived

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Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes

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