NCT04339530

Brief Summary

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

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 9, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

May 10, 2021

Status Verified

May 1, 2021

Enrollment Period

3 years

First QC Date

April 3, 2020

Last Update Submit

May 7, 2021

Conditions

OverweightObesity

Keywords

Vitamin DType 2 diabetesInsulin resistanceGlucose

Outcome Measures

Primary Outcomes (1)

  • 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 (5)

  • Fasting bood glucose levels

    One venous sample collected after 8 hours of fasting

  • HbA1C

    Sample collected at one single time point with no follow-up

  • Body fat percentage

    Measurement conducted in the morning after 8 hours of fasting

  • Central and brachial Systolic and Diastolic Blood pressure

    Measurement taken 3 times after a-10 minute rest

  • Augmentation index

    Measurement taken 3 times after a-10 minute rest

Interventions

Normal weight and overweight adultsOTHER

Association between vitamin D levels and insulin resistance

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Normal weight and overweight and obese adults (BMI\>= 18.5 Kg/m2) with no restriction to ethnicity, occupation or socioeconomic status.
  • Males and females
  • years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Health sciences

Liverpool, L1 9JD, United Kingdom

Location

MeSH Terms

Conditions

OverweightObesityDiabetes Mellitus, Type 2Insulin Resistance

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 3, 2020

First Posted

April 9, 2020

Study Start

July 1, 2019

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

May 10, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)