Vitamin D and Type 2 Diabetes Risk in UK Adults | NCT04339530

Studies
Vitamin D and Type 2 Diabetes Risk in UK Adults

NCT04339530

Sponsor

Liverpool Hope University

Status

Suspended

Last Update Posted

May 10, 2021Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Overweight
Obesity

Interventions

Normal weight and overweight adults

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This study is suspended until further notice. Recruitment should resume when COVID-19 safety restrictions are lifted.

Expanded Access Info

Start Date

Jul 1, 2019Actual

Primary Completion Date

Jul 1, 2022Estimated

Completion Date

Jul 1, 2022Estimated

First Submitted Date

Apr 3, 2020

First Submission Date that Met QC Criteria

Apr 7, 2020

First Posted Date

Apr 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2021

Last Update Posted Date

May 10, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Grace Farhat, Principal Investigator, Liverpool Hope UniversityPrincipal Investigator

Lead Sponsor

Liverpool Hope UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Normal weight and overweight adults	Other	Association between vitamin D levels and insulin resistance

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Fasting bood glucose levels	A venous blood sample collected for the measurement of glucose levels	One venous sample collected after 8 hours of fasting
HbA1C	Fingerprick sample

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Overweight and obese adults , aged 18-50 (premenopausal women), males and females with no known chronic conditions.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
School of Health sciences		Liverpool		L1 9JD	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050177	Overweight
D009765	Obesity
D003924	Diabetes Mellitus, Type 2
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided