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Diabetes Intervention Trial With Vitamin D in Subjects of Nordic and Sub-Indian Ethnicity (DIVINE)

Primary Purpose

Diabetes Mellitus Type 2, Hypovitaminosis D

Status

Unknown status

Phase

Phase 2

Locations

Norway

Study Type

Interventional

Intervention

Cholecalciferol

Orange juice

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2 focused on measuring Insulin resistance, Insulin secretory dysfunction, Inflammation, Vascular stiffness

Eligibility Criteria

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

Inclusion criteria:

Moderate (S-25OHD 25-50 nmol/l) to severe (S-25OHD < 25 nmol/l) vitamin D deficiency measured at Visit 1.
Patients with type 2 diabetes, including drug naïve subjects, subjects using oral anti-diabetic medication and subjects on insulin treatment. All medication must be in stable doses during the 4 week lead-in period.
HbA1c < 11 % at Visit 1.
Able to communicate in Norwegian.
Men and women ≥ 18 years.
Norwegian or South Asian ethnicity.
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study. All WOCBP must have negative serum or urine pregnancy test at enrollment, randomization, titration visit and final study assessment.
Antihypertensive medication, lipid lowering drugs, oral contraceptives, hormone replacement therapy, multivitamin supplements and nutritional supplements are allowed if the subjects adhere to the same regimen during the study

Exclusion Criteria:

Subjects not having type 2 diabetes.
SBP ≥ 160 or DBP ≥ 95 at Visit 1.
Significant renal disease or chronic renal impairment, GFR< 30 ml/min.
Significant liver disease or ASAT or ALAT >3x UNL.
Malignancy during the last five years.
Hypercalcemia at Visit 1.
A history of kidney stone disease
WOCBP unwilling or unable to use an acceptable method to avoid pregnancy.
Pregnant or breastfeeding women.
Chronic inflammatory disease in active phase
Long term (>2 weeks) use of corticosteroids last 3 months
Mental condition (psychiatric or organic cerebral disease) rendering the subject unable to understand the nature, scope and possible consequences of the study.
Drug or alcohol abuse.
BMI > 45 kg/m2 or bariatric surgery (<5 years).
Anemia
Cardiovascular disease (myocardial infarction, unstable angina pectoris or stroke) during the last 6 months.
Any medical condition that in the judgment of the investigator would jeopardize the subject's safety or evaluation of the study drug for efficacy and safety.

Sites / Locations

Diabetes Laboratory, Oslo University Hospital AkerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cholecalciferol

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Insulin sensitivity measured with euglycemic, hyperinsulinemic clamp

Secondary Outcome Measures

Insulin secretion measured with IVGTT

Physical activity/muscle strength

HbA1c and fasting glucose

Arterial stiffness

Differences in inflammatory markers, endothelial function and bone specific laboratory markers.

Safety of this regimen of vitamin D3 supplementation; subjects will be assessed for hypercalcemia and renal dysfunction.

Change from baseline in quality of life score between groups (SF-36).

Effect on serum lipid levels and other biochemical markers

Metabolomics analyses.

Full Information

NCT ID

NCT00992797

First Posted

October 5, 2009

Last Updated

November 2, 2009

Sponsor

University Hospital, Aker

Collaborators

University of Oslo

1. Study Identification

Unique Protocol Identification Number

NCT00992797

Brief Title

Diabetes Intervention Trial With Vitamin D in Subjects of Nordic and Sub-Indian Ethnicity

Acronym

DIVINE

Official Title

A Randomized Controlled Trial of the Effect of Vitamin D Supplementation on Insulin Sensitivity and Secretion in Subjects With Type 2 Diabetes of Nordic and Sub-Indian Ethnicity .

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Unknown status

Study Start Date

September 2009 (undefined)

Primary Completion Date

December 2010 (Anticipated)

Study Completion Date

December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Aker

Collaborators

University of Oslo

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this 6 months study is to evaluate the metabolic effects of 400.000-600.000 IU of vitamin D supplementation in subjects with type 2 diabetes and hypovitaminosis D. The main hypothesis is that subjects with low levels of 25-OH-vitamin D will benefit from supplementation with cholecalciferol in sufficient doses to optimize serum levels.

Detailed Description

Accumulating evidence suggests that hypovitaminosis D may be associated with the development of type 2 diabetes and disturbances in glucose and insulin metabolism. There is lack of data from randomized, controlled studies of sufficient duration and with the use of sufficient doses of vitamin D to assess the importance of vitamin D supplementation in glucose metabolism in type 2 diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus Type 2, Hypovitaminosis D

Keywords

Insulin resistance, Insulin secretory dysfunction, Inflammation, Vascular stiffness

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cholecalciferol

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Cholecalciferol

Other Intervention Name(s)

Vitamin D, ZymaD

Intervention Description

Cholecalciferol 200.000 IU pr ampoule, 400.000 IU given at randomization day, followed by additionally 200.000 IU at week 5 if serum 25(OH)D < 100 nmol/L. If serum 25(OH)D > 100 placebo will be given. The cholecalciferol will be given in orange juice.

Intervention Type

Other

Intervention Name(s)

Orange juice

Intervention Description

Orange juice at randomization day and at week 5.

Primary Outcome Measure Information:

Title

Insulin sensitivity measured with euglycemic, hyperinsulinemic clamp

Time Frame

Before and after the 6 months intervention period

Secondary Outcome Measure Information:

Title

Insulin secretion measured with IVGTT

Time Frame

At 0 and 6 months

Title

Physical activity/muscle strength

Time Frame

At 0 and 6 months

Title

HbA1c and fasting glucose

Time Frame

At 0, 3 and 6 months

Title

Arterial stiffness

Time Frame

At 0 and 6 months

Title

Differences in inflammatory markers, endothelial function and bone specific laboratory markers.

Time Frame

At 0, 3 and 6 months

Title

Safety of this regimen of vitamin D3 supplementation; subjects will be assessed for hypercalcemia and renal dysfunction.

Time Frame

Entire intervention period, samples taken at 0,1,3, and 6 months

Title

Change from baseline in quality of life score between groups (SF-36).

Time Frame

At 0 and 6 months

Title

Effect on serum lipid levels and other biochemical markers

Time Frame

At 0, 3 and 6 months

Title

Metabolomics analyses.

Time Frame

At 0 and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Moderate (S-25OHD 25-50 nmol/l) to severe (S-25OHD < 25 nmol/l) vitamin D deficiency measured at Visit 1. Patients with type 2 diabetes, including drug naïve subjects, subjects using oral anti-diabetic medication and subjects on insulin treatment. All medication must be in stable doses during the 4 week lead-in period. HbA1c < 11 % at Visit 1. Able to communicate in Norwegian. Men and women ≥ 18 years. Norwegian or South Asian ethnicity. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study. All WOCBP must have negative serum or urine pregnancy test at enrollment, randomization, titration visit and final study assessment. Antihypertensive medication, lipid lowering drugs, oral contraceptives, hormone replacement therapy, multivitamin supplements and nutritional supplements are allowed if the subjects adhere to the same regimen during the study Exclusion Criteria: Subjects not having type 2 diabetes. SBP ≥ 160 or DBP ≥ 95 at Visit 1. Significant renal disease or chronic renal impairment, GFR< 30 ml/min. Significant liver disease or ASAT or ALAT >3x UNL. Malignancy during the last five years. Hypercalcemia at Visit 1. A history of kidney stone disease WOCBP unwilling or unable to use an acceptable method to avoid pregnancy. Pregnant or breastfeeding women. Chronic inflammatory disease in active phase Long term (>2 weeks) use of corticosteroids last 3 months Mental condition (psychiatric or organic cerebral disease) rendering the subject unable to understand the nature, scope and possible consequences of the study. Drug or alcohol abuse. BMI > 45 kg/m2 or bariatric surgery (<5 years). Anemia Cardiovascular disease (myocardial infarction, unstable angina pectoris or stroke) during the last 6 months. Any medical condition that in the judgment of the investigator would jeopardize the subject's safety or evaluation of the study drug for efficacy and safety.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gulseth Wium, MD

Phone

4722894745

diabeteslab@aus.no

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kåre I Birkeland, MD PhD

Organizational Affiliation

Oslo University Hospital, Aker

Official's Role

Principal Investigator

Facility Information:

Facility Name

Diabetes Laboratory, Oslo University Hospital Aker

City

Oslo

ZIP/Postal Code

0514

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

Phone

4722894745

diabeteslab@aus.no

First Name & Middle Initial & Last Name & Degree

Kåre I Birkeland, MD PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

28468770

Citation

Gulseth HL, Wium C, Angel K, Eriksen EF, Birkeland KI. Effects of Vitamin D Supplementation on Insulin Sensitivity and Insulin Secretion in Subjects With Type 2 Diabetes and Vitamin D Deficiency: A Randomized Controlled Trial. Diabetes Care. 2017 Jul;40(7):872-878. doi: 10.2337/dc16-2302. Epub 2017 May 3.

Results Reference

derived

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Diabetes Intervention Trial With Vitamin D in Subjects of Nordic and Sub-Indian Ethnicity

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