Diabetes Mellitus, Non-Insulin-DependentNCT00320853
A Study to Evaluate the Effect of Vitamin D Supplementation on Insulin Sensitivity and Secretion
A study testing Vitamin D in people with Diabetes Mellitus, Non-Insulin-Dependent, run by Sitaram Bhartia Institute of Science and Research at 1 site in India.
Trial summary
The purpose of the study is to evaluate the change in insulin sensitivity and secretion indices (early markers for development of diabetes) after 4 weeks of a megadose of Vitamin D. Read more about this study
- Who is it for?
- Ages 30 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Non-Insulin-Dependent
- What is being tested?
- Vitamin D
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2006to May 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- ≥30 years of age
- Waist circumference ≥80 cm
Who cannot join
- Diabetic- Fasting Blood Sugar >126 mg/dl or on anti-diabetic medication
- BP>140/90 or on anti-hypertensive medication
- Receiving Vitamin D or calcium supplementation
- Chronic disease-renal/hepatic/malignancy/gastrointestinal
- On any medication within the last one month which could potentially influence insulin secretion, insulin sensitivity, Vitamin D or Calcium metabolism
- Febrile illness or infective morbidity in the past 10 days
Trial locations and contacts
1 site in 1 country.
India1 site
Sitaram Bhartia Institute of Science and Research
New Delhi, National Capital Territory of Delhi, 110016
About this study
Official title: A Pilot Study to Evaluate the Effect of Vitamin D Supplementation on Insulin Secretion and Peripheral Insulin Sensitivity
The purpose of the study is to evaluate the change in insulin sensitivity and secretion indices (early markers for development of diabetes) after 4 weeks of a megadose of Vitamin D. This will also help to calculate sample size for and choose an appropriate index for a larger randomized control trial which may be required subsequently.
Read the detailed description
Accumulating evidence suggests that serum Vitamin D levels may be inversely related to the prevalence of diabetes, to the concentration of glucose , insulin resistance and metabolic syndrome.The available trials have been conducted using small sample sizes in different subgroups (hemodialyzed patients , healthy volunteers , gestational diabetes and post menopausal women ) document variable results with a positive result in some (hemodialysis and gestational diabetes) and no effect in other settings(healthy volunteers and postmenopausal women).We therefore, planned this trial to study the effect of vitamin D supplementation (240,000 IU) on insulin secretion and peripheral insulin sensitivity.This will also help to calculate sample size for and choose an appropriate index for a larger randomized control trial which may be required subsequently.
Study design and comparison:Single group, open label intervention trial involving assessment of insulin sensitivity and secretion in 30 volunteers before and after 4weeks of a megadose of Vitamin D. The pre and post intervention results will be compared using the paired t test.
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Being tested
- Vitamin D
- Keywords
- Diabetes, Vitamin D, Insulin sensitivity, Insulin secretion
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
OGIS Index, Total Insulin Secretion
Secondary outcomes (10)
HOMA
QUICKI
ISI composite
ISI stumvoll
ISI Gutt
Insulinogenic Index
Lipid profile
CRP
ApoA1
ApoB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startApr 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Non-Insulin-DependentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Sitaram Bhartia Institute of Science and Research
- Sponsor type
- University, hospital or other
- Investigators
- Jitendra N Pande, MD, Principal investigator, Sitaram Bhartia Institute of Science and ResearchJitender Nagpal, MD, Principal investigator, Sitaram Bhartia Institute of Science and ResearchAbhishek Bhartia, ME, Study director, Sitaram Bhartia Institute of Science and ResearchAnupama Singh, MD, Study chair, Sitaram Bhartia Institute of Science and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00320853
- Sponsor's protocol ID
- SBISR/2006/02
- Status last verified
- May 2006
- First submitted
- 1 May 2006
- Last updated
- 3 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Effect of Vitamin D Supplementation on Insulin Secretion and Peripheral Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT00320853
- Acronym / sponsor ID
- SBISR/2006/02
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Keywords
- Diabetes, Vitamin D, Insulin sensitivity, Insulin secretion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Sitaram Bhartia Institute of Science and ResearchUniversity, hospital or other
- Study start
- Apr 2006
- Study completion
- May 2006
- First posted
- 3 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the change in insulin sensitivity and secretion indices (early markers for development of diabetes) after 4 weeks of a megadose of Vitamin D. This will also help to calculate sample size for and choose an appropriate index for a larger randomized control trial which may be required subsequently.
Detailed description
Accumulating evidence suggests that serum Vitamin D levels may be inversely related to the prevalence of diabetes, to the concentration of glucose , insulin resistance and metabolic syndrome.The available trials have been conducted using small sample sizes in different subgroups (hemodialyzed patients , healthy volunteers , gestational diabetes and post menopausal women ) document variable results with a positive result in some (hemodialysis and gestational diabetes) and no effect in other settings(healthy volunteers and postmenopausal women).We therefore, planned this trial to study the effect of vitamin D supplementation (240,000 IU) on insulin secretion and peripheral insulin sensitivity.This will also help to calculate sample size for and choose an appropriate index for a larger randomized control trial which may be required subsequently.
Study design and comparison:Single group, open label intervention trial involving assessment of insulin sensitivity and secretion in 30 volunteers before and after 4weeks of a megadose of Vitamin D. The pre and post intervention results will be compared using the paired t test.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male
- ≥30 years of age
- Waist circumference ≥80 cm
Key exclusion criteria (6 listed)
- Diabetic- Fasting Blood Sugar >126 mg/dl or on anti-diabetic medication
- BP>140/90 or on anti-hypertensive medication
- Receiving Vitamin D or calcium supplementation
- Chronic disease-renal/hepatic/malignancy/gastrointestinal
- On any medication within the last one month which could potentially influence insulin secretion, insulin sensitivity, Vitamin D or Calcium metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D | Drug | – |
Primary outcome
OGIS Index, Total Insulin Secretion
10 secondary outcomes
HOMA
QUICKI
ISI composite
ISI stumvoll
ISI Gutt
Insulinogenic Index
Lipid profile
CRP
ApoA1
ApoB
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jitendra N Pande, MD principal investigator
Sitaram Bhartia Institute of Science and Research
Jitender Nagpal, MD principal investigator
Sitaram Bhartia Institute of Science and Research
Abhishek Bhartia, ME study director
Sitaram Bhartia Institute of Science and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Diabetes Mellitus, Non-Insulin-Dependent, run by Sitaram Bhartia Institute of Science and Research at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OGIS Index, Total Insulin Secretion. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2006.