- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04339530
Vitamin D and Type 2 Diabetes Risk in UK Adults
May 7, 2021 updated by: Grace Farhat, Liverpool Hope University
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.
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Liverpool, United Kingdom, L1 9JD
- School of Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Overweight and obese adults , aged 18-50 (premenopausal women), males and females with no known chronic conditions.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
One venous sample collected after 8 hours of fasting
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fasting bood glucose levels
Time Frame: One venous sample collected after 8 hours of fasting
|
A venous blood sample collected for the measurement of glucose levels
|
One venous sample collected after 8 hours of fasting
|
HbA1C
Time Frame: Sample collected at one single time point with no follow-up
|
Fingerprick sample
|
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
|
Body fat percentage measured through DEXA
|
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
|
Blood pressure measured using a digital sphygmomanometer
|
Measurement taken 3 times after a-10 minute rest
|
Augmentation index
Time Frame: Measurement taken 3 times after a-10 minute rest
|
Arterial stiffness assessment test
|
Measurement taken 3 times after a-10 minute rest
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2019
Primary Completion (Anticipated)
July 1, 2022
Study Completion (Anticipated)
July 1, 2022
Study Registration Dates
First Submitted
April 3, 2020
First Submitted That Met QC Criteria
April 7, 2020
First Posted (Actual)
April 9, 2020
Study Record Updates
Last Update Posted (Actual)
May 10, 2021
Last Update Submitted That Met QC Criteria
May 7, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7062019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Fundació Sant Joan de DéuNot yet recruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Normal weight and overweight adults
-
Applied Science Private UniversityUnknownAtherosclerosisJordan
-
Virginia Polytechnic Institute and State UniversityRecruiting
-
Landspitali University HospitalUniversity of Iceland; University College Cork; European Commission; University... and other collaboratorsUnknownOverweight | Bone Resorption | Metabolic Syndrome X
-
Istanbul Medipol University HospitalMarmara UniversityCompletedEarly Intervention | Term Infants | Low Birth Weight Infants
-
Virginia Commonwealth UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedObesityUnited States
-
Maimonides Medical CenterJohnson & Johnson Pharmaceutical Research & Development, L.L.C.RecruitingAnkle Fractures | Syndesmotic Injuries | Bimalleolar Fractures | Trimalleolar Fractures | Ankle Dislocation | Bimalleolar Equivalent Fracture | Maisonneuve FractureUnited States
-
University of AarhusChild and Youth, Aarhus MunicipalityCompletedPediatric ObesityDenmark
-
University Hospital, BordeauxInstitut National de la Santé Et de la Recherche Médicale, FranceCompleted
-
Washington University School of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedObesity | Menopause | Sarcopenia | OsteoporosisUnited States
-
University of CopenhagenCompleted