OverweightNCT04339530
Vitamin D and Type 2 Diabetes Risk in UK Adults
An observational study of Overweight and Obesity, run by Liverpool Hope University at 1 site in United Kingdom.
Trial summary
This study is exploring the association between vitamin D and Type 2 diabetes risk in normal weight and overweight UK adults. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Normal weight and overweight adults
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2019to 1 Jul 2022
- Phase
- Observational
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Overweight and obese adults , aged 18-50 (premenopausal women), males and females with no known chronic conditions.
Who may be able to join
- Normal weight and overweight and obese adults (BMI>= 18.5 Kg/m2) with no restriction to ethnicity, occupation or socioeconomic status.
- Males and females
- 18-50 years
Who cannot join
- Patients diagnosed with diabetes type 2, myocardial infarction or coronary heart disease.
- HbA1c > 6.4%
- Pregnancy
- Diagnosis of liver disease (including liver enzymes > 3 times above normal values)
- Diagnosis of renal disease (creatinine of > 150 mmol/l)
- Post-menopausal women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Vitamin D Status and Risk of Type 2 Diabetes in a Population of UK Adults: A Cross-sectional Study.
This study is exploring the association between vitamin D and Type 2 diabetes risk in normal weight and overweight UK adults.
Read the detailed description
The aim of this study is to assess the link between vitamin D status and glucose homeostasis in a population of normal weight and overweight individuals (BMI> 18.5 Kg/m2).
- Conditions
- Overweight, Obesity
- Being tested
- Normal weight and overweight adults
- Keywords
- Vitamin D, Type 2 diabetes, Insulin resistance, Glucose
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal weight and overweight adultsOther
Association between vitamin D levels and insulin resistance
What is being measured
The primary outcome is the main question the study is designed to answer.
HOMA-IR (Homeostasis modelling assessment-Insulin resistance)
A venous blood sample collected for the measurement of insulin and glucose levels.
Measured: One venous sample collected after 8 hours of fasting
Secondary outcomes (5)
Fasting bood glucose levels
A venous blood sample collected for the measurement of glucose levels
Measured: One venous sample collected after 8 hours of fasting
HbA1C
Fingerprick sample
Measured: Sample collected at one single time point with no follow-up
Body fat percentage
Body fat percentage measured through DEXA
Measured: Measurement conducted in the morning after 8 hours of fasting
Central and brachial Systolic and Diastolic Blood pressure
Blood pressure measured using a digital sphygmomanometer
Measured: Measurement taken 3 times after a-10 minute rest
Augmentation index
Arterial stiffness assessment test
Measured: Measurement taken 3 times after a-10 minute rest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start1 Jul 2019
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Why it stopped: This study is suspended until further notice. Recruitment should resume when COVID-19 safety restrictions are lifted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool Hope University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grace Farhat, Liverpool Hope University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339530
- Sponsor's protocol ID
- 7062019
- Status last verified
- May 2021
- First submitted
- 3 Apr 2020
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Vitamin D Status and Risk of Type 2 Diabetes in a Population of UK Adults: A Cross-sectional Study.
- ClinicalTrials.gov ID
- NCT04339530
- Acronym / sponsor ID
- 7062019
- Conditions
- Overweight, Obesity
- Keywords
- Vitamin D, Type 2 diabetes, Insulin resistance, Glucose
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: This study is suspended until further notice. Recruitment should resume when COVID-19 safety restrictions are lifted.
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Liverpool Hope UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 9 Apr 2020 (actual)
- 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.
This study is exploring the association between vitamin D and Type 2 diabetes risk in normal weight and overweight UK adults.
Detailed description
The aim of this study is to assess the link between vitamin D status and glucose homeostasis in a population of normal weight and overweight individuals (BMI> 18.5 Kg/m2).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Overweight and obese adults , aged 18-50 (premenopausal women), males and females with no known chronic conditions.
Key inclusion criteria (3 listed)
- Normal weight and overweight and obese adults (BMI>= 18.5 Kg/m2) with no restriction to ethnicity, occupation or socioeconomic status.
- Males and females
- 18-50 years
Key exclusion criteria (6 listed)
- Patients diagnosed with diabetes type 2, myocardial infarction or coronary heart disease.
- HbA1c > 6.4%
- Pregnancy
- Diagnosis of liver disease (including liver enzymes > 3 times above normal values)
- Diagnosis of renal disease (creatinine of > 150 mmol/l)
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 |
|---|---|---|
| Normal weight and overweight adultsAssociation between vitamin D levels and insulin resistance | Other | – |
Primary outcome
HOMA-IR (Homeostasis modelling assessment-Insulin resistance)
Time frame: One venous sample collected after 8 hours of fasting
A venous blood sample collected for the measurement of insulin and glucose levels.
5 secondary outcomes
Fasting bood glucose levels
Time frame: One venous sample collected after 8 hours of fasting
HbA1C
Time frame: Sample collected at one single time point with no follow-up
Body fat percentage
Time frame: Measurement conducted in the morning after 8 hours of fasting
Central and brachial Systolic and Diastolic Blood pressure
Time frame: Measurement taken 3 times after a-10 minute rest
Augmentation index
Time frame: Measurement taken 3 times after a-10 minute rest
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by Liverpool Hope University at 1 site in United Kingdom.
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: paused, as of the sponsor's last update on 10 May 2021. 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 United Kingdom. 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?
Results are not available in the source record.
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?
HOMA-IR (Homeostasis modelling assessment-Insulin resistance) (time frame: One venous sample collected after 8 hours of fasting). 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 10 May 2021.