Vitamin D for the Prevention of Diabetes Type 2

Impaired Glucose Tolerance Clinical Trial

Official title:

Prevention of Type 2 Diabetes With Vitamin D Supplementation in Subjects With Reduced Glucose Tolerance Detected in the Tromso Study 2007/2008

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00685594
• Other study ID #: UIT-ENDO-2008-1
• Secondary ID: NFR 184766/V50
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 9, 2008
• Last updated: September 18, 2015
• Start date: March 2008
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: University of Tromso
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The prevalence of type 2 diabetes is increasing, which for most societies has considerable consequences not only regarding health but also economy. Type 2 diabetes develops through a "prediabetic" stage with impaired glucose tolerance. Intervention at this stage with change in lifestyle or with medication may prevent such progression. There are indications that vitamin D is of importance in glucose metabolism, and that supplementation with vitamin D may increase both insulin secretion and insulin sensitivity. Accordingly, supplementation with vitamin D may improve glucose tolerance and potentially prevent the development of type 2 diabetes in subjects at risk. However, this has so far not been demonstrated in a prospective, randomised clinical study. In the present study we will therefore include 600 subjects with impaired glucose tolerance (or impaired fasting glucose) detected in the Tromso study 2007/2008 and randomize to supplementation with vitamin D 20.000IU per week or placebo for 5 years. A glucose tolerance test will be performed each year, and development of type 2 diabetes will be the main endpoint.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. completion date: September 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• Impaired glucose tolerance

Exclusion Criteria:

• Serious heart disease

• Renal stone disease

• Hypercalcemia

• Sarcoidosis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Glucose Tolerance

Intervention

Drug:
• cholecalciferol
20.000 IU cholecalciferol per week for 5 years versus placebo
• Placebo
Placebo capsule once a week, identical to cholecalciferol capsule

Locations

Country	Name	City	State
Norway	University of Tromso	Tromso

Sponsors (2)

Lead Sponsor	Collaborator
University of Tromso	University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oral glucose tolerance response to vitamin D supplementation in relation to polymorphisms in the vitamin D system	The response to oral glucose tolerance test (fasting and 2 h blood glucose, serum insulin, C-peptide, measures of insulin resistiance as well as metabolic parameters (lipids, blood pressure)) will be evaluated in the results at the 1-year visit in relation to genetic polymorphisms in the vitamin D system	1 year	No
Primary	development of diabetes type 2		5 years	No
Secondary	change in glucose metabolism		5 years	No
Secondary	change in lipid status		5 years	No
Secondary	change in mood		5 years	No
Secondary	change in BMD hip		5 years	No
Secondary	change in intima media thickness carotid artery		5 years	No
Secondary	change in frequency of infections		5 years	No
Secondary	change in blood pressure		5 years	No
Secondary	Change in Insulin sensitivity		5 years	No
Secondary	change in HbA1c		5 years	No
Secondary	change in weight		5 years	No
Secondary	change in telomer length		5 years	No