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

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.

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

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.

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