Vitamin D and Type 2 Diabetes Risk in UK Adults

Obesity Clinical Trial

Official title:

Association Between Vitamin D Status and Risk of Type 2 Diabetes in a Population of UK Adults: A Cross-sectional Study.

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04339530
• Other study ID #: 7062019
• Status: Suspended
• Start date: July 1, 2019
• Est. completion date: July 1, 2022

Study information

• Verified date: May 2021
• Source: Liverpool Hope University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is exploring the association between vitamin D and Type 2 diabetes risk in normal weight and overweight UK adults.

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).

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 300
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Overweight

Intervention

Other:
• Normal weight and overweight adults
Association between vitamin D levels and insulin resistance

Locations

Country	Name	City	State
United Kingdom	School of Health sciences	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
Liverpool Hope University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HOMA-IR (Homeostasis modelling assessment-Insulin resistance)	A venous blood sample collected for the measurement of insulin and glucose levels.	One venous sample collected after 8 hours of fasting
Secondary	Fasting bood glucose levels	A venous blood sample collected for the measurement of glucose levels	One venous sample collected after 8 hours of fasting
Secondary	HbA1C	Fingerprick sample	Sample collected at one single time point with no follow-up
Secondary	Body fat percentage	Body fat percentage measured through DEXA	Measurement conducted in the morning after 8 hours of fasting
Secondary	Central and brachial Systolic and Diastolic Blood pressure	Blood pressure measured using a digital sphygmomanometer	Measurement taken 3 times after a-10 minute rest
Secondary	Augmentation index	Arterial stiffness assessment test	Measurement taken 3 times after a-10 minute rest