Vitamin D and Type 2 Diabetes Risk in UK Adults

Suspended

• Conditions: Obesity; Overweight

• Registration Number: NCT04339530
• Lead Sponsor: Liverpool Hope University

Brief Summary

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 Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2020-04-03
• Study First Submitted QC: 2020-04-07
• Study First Posted: 2020-04-09
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-07
• Last Update Posted: 2021-05-10
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HOMA-IR (Homeostasis modelling assessment-Insulin resistance)	One venous sample collected after 8 hours of fasting	A venous blood sample collected for the measurement of insulin and glucose levels.

Secondary Outcome Measures

Name	Time	Method
Fasting bood glucose levels	One venous sample collected after 8 hours of fasting	A venous blood sample collected for the measurement of glucose levels
HbA1C	Sample collected at one single time point with no follow-up	Fingerprick sample
Body fat percentage	Measurement conducted in the morning after 8 hours of fasting	Body fat percentage measured through DEXA
Central and brachial Systolic and Diastolic Blood pressure	Measurement taken 3 times after a-10 minute rest	Blood pressure measured using a digital sphygmomanometer
Augmentation index	Measurement taken 3 times after a-10 minute rest	Arterial stiffness assessment test

Trial Locations

Locations (1)

School of Health sciences; 🇬🇧 Liverpool, United Kingdom