PrediabetesPhase 4NCT01436916
Oral Cholecalciferol in Prevention of Type 2 Diabetes Mellitus
A Phase 4 study testing oral cholecalciferol + life style counselling in people with Prediabetes and Vitamin D Deficiency, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Type 2 diabetes mellitus (T2DM) is a major public health problem .Prevalence of vitamin D deficiency is also high i.e. 78-96% in different groups of population in north India. Observational studies find association between low Vitamin D status and type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Prediabetes, Vitamin D Deficiency
- What is being tested?
- oral cholecalciferol + life style counselling
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2011to Dec 2012
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults > 20 years
- Impaired fasting glucose (IFG) - FPG 100-125 mg/dl
- Impaired glucose tolerance((IGT)- 2hr PPG 140-199mg/dl
- OR
- both ( IFG +IGT)
- with or without Hb A1c -5.7-6.4 %
- WITH
- Asymptomatic Vitamin D deficiency(< 20ng/ml) or vitamin D in sufficiency(< 32ng/ml)
Who cannot join
- Diabetes mellitus,
- Base line 25(OH)D3 > 32 ng/ml,
- Symptomatic vitamin D deficiency,
- Any medication within last month that could affect insulin secretion, insulin sensitivity , vitamin D and calcium metabolism
- Chronic renal , hepatic ,malignant, intestinal or endocrine diseases
- Febrile illness or infective morbidity in last 2 weeks,
- Grossly deranged liver and kidney function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Cholecalciferol in Prevention of Type 2 DM in Prediabetic Population With Vitamin D Insufficiency
Type 2 diabetes mellitus (T2DM) is a major public health problem .Prevalence of vitamin D deficiency is also high i.e. 78-96% in different groups of population in north India. Observational studies find association between low Vitamin D status and type 2 diabetes mellitus. Prediabetes is a condition that progress to diabetes at a rate of 6-10% per year .There is mechanistic support that vitamin D may influence both insulin secretion and insulin sensitivity and subsequently T2DM incidence. In general, cross-sectional and prospective studies support the role of vitamin D in the prevention of T2DM. This study will be a single blind randomized placebo controlled trial to study the effect of oral cholecalciferol in insulin sensitivity and secretion in adults with prediabetes who are also vitamin D insufficient.
- Conditions
- Prediabetes, Vitamin D Deficiency
- Being tested
- oral cholecalciferol + life style counselling, placebo + life style counselling
- Keywords
- prediabetes, oral cholecalciferol
- Medical subject headings
- Prediabetic State, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral cholecalciferol + life style counsellingDrug
oral cholecalciferol 600000 units loading then 60000 units fortnightly for 6months
placebo + life style counsellingDrug
Will provide placebo 10 sachets loading and then single sachet fortnightly for 6 months
| Study group | Role | What they receive |
|---|---|---|
| oral cholecalciferol + lifestyle counselling | Active comparator | will receive Oral cholecalciferol Receives: Drug: oral cholecalciferol + life style counselling |
| Placebo + lifestyle counselling | Placebo comparator | will receive placebo Receives: Drug: placebo + life style counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin sensitivity using OGIS (oral glucose insulin sensitivity index)
Measured: Base line and 6 months
Secondary outcomes (4)
change in indices of insulin secretion using HOMA1-beta% and HOMA2-beta %
Measured: Base line and 6 months
change in other insulin sensitivity indices
QUICKI, HOMA 1-IR ,HOMA2- IR ,WBISI( Matsuda index),hepatic and muscle insulin sensitvity indices
Measured: Base line and 6 months
Change in Hb A1c
Measured: Base line and 6 months
Change in fasting and post prandial blood glucose
Measured: 0,3, 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anil Bhansali, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Anil Bhansali, MD, DM, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436916
- Sponsor's protocol ID
- 0023051981
- Status last verified
- Oct 2015
- First submitted
- 13 Sep 2011
- Last updated
- 26 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Cholecalciferol in Prevention of Type 2 DM in Prediabetic Population With Vitamin D Insufficiency
- ClinicalTrials.gov ID
- NCT01436916
- Acronym / sponsor ID
- 0023051981
- Conditions
- Prediabetes, Vitamin D Deficiency
- Keywords
- prediabetes, oral cholecalciferol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Sep 2011 (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.
Type 2 diabetes mellitus (T2DM) is a major public health problem .Prevalence of vitamin D deficiency is also high i.e. 78-96% in different groups of population in north India. Observational studies find association between low Vitamin D status and type 2 diabetes mellitus. Prediabetes is a condition that progress to diabetes at a rate of 6-10% per year .There is mechanistic support that vitamin D may influence both insulin secretion and insulin sensitivity and subsequently T2DM incidence. In general, cross-sectional and prospective studies support the role of vitamin D in the prevention of T2DM. This study will be a single blind randomized placebo controlled trial to study the effect of oral cholecalciferol in insulin sensitivity and secretion in adults with prediabetes who are also vitamin D insufficient.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral cholecalciferol + lifestyle counselling | Active comparator | Drug: oral cholecalciferol + life style counsellingwill receive Oral cholecalciferol |
| Placebo + lifestyle counselling | Placebo comparator | Drug: placebo + life style counsellingwill receive placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults > 20 years
- Impaired fasting glucose (IFG) - FPG 100-125 mg/dl
- Impaired glucose tolerance((IGT)- 2hr PPG 140-199mg/dl
- OR
- both ( IFG +IGT)
Key exclusion criteria (7 listed)
- Diabetes mellitus,
- Base line 25(OH)D3 > 32 ng/ml,
- Symptomatic vitamin D deficiency,
- Any medication within last month that could affect insulin secretion, insulin sensitivity , vitamin D and calcium metabolism
- Chronic renal , hepatic ,malignant, intestinal or endocrine diseases
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 |
|---|---|---|
| oral cholecalciferol + life style counsellingoral cholecalciferol 600000 units loading then 60000 units fortnightly for 6months | Drug | oral cholecalciferol + lifestyle counselling |
| placebo + life style counsellingWill provide placebo 10 sachets loading and then single sachet fortnightly for 6 months | Drug | Placebo + lifestyle counselling |
Primary outcome
Change in insulin sensitivity using OGIS (oral glucose insulin sensitivity index)
Time frame: Base line and 6 months
4 secondary outcomes
change in indices of insulin secretion using HOMA1-beta% and HOMA2-beta %
Time frame: Base line and 6 months
change in other insulin sensitivity indices
Time frame: Base line and 6 months
Change in Hb A1c
Time frame: Base line and 6 months
Change in fasting and post prandial blood glucose
Time frame: 0,3, 6months
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 26 Oct 2015.
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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.
Anil Bhansali, MD, DM principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oral cholecalciferol + life style counselling in people with Prediabetes and Vitamin D Deficiency, run by Post Graduate Institute of Medical Education and Research, Chandigarh 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 8 inclusion and 7 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 26 Oct 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in insulin sensitivity using OGIS (oral glucose insulin sensitivity index) (time frame: Base line and 6 months). 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 26 Oct 2015.