NCT04446754

Brief Summary

This study investigates the association of genetic effects of rs7903146 and dietary intake on type 2 Diabetes Mellitus (T2DM) risk in a healthy population. T2DM risk was assessed through glycated haemoglobin (HbA1c) concentration in 73 subjects. Dietary intake was assessed using a validated food frequency questionnaire (FFQ).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 10, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2019

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
Last Updated

June 25, 2020

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

June 19, 2020

Last Update Submit

June 23, 2020

Conditions

Health BehaviorBlood Glucose, HighDiet HabitGenetic Predisposition

Outcome Measures

Primary Outcomes (3)

  • DNA

    salivary (1-ml) DNA for genotype TCF7L2 gene (rs7903146 SNP)

    3 months

  • Hba1c

    capillary blood collected (via the ears or fingers) using a Microvette CB Lithium Heparin tube (SARSTEDT AG \& C0., Nümbrecht, Germany)

    3 months

  • Diet intake

    Dietary intake estimated using The European Prospective Investigation into Cancer and Nutrition (EPIC)-Norfolk (food frequency questionnaire)

    3 months

Secondary Outcomes (7)

  • Body weight

    3 months

  • Waist

    3 months

  • Hip

    3 months

  • Height

    3 months

  • Physical activity

    3 months

  • +2 more secondary outcomes

Eligibility Criteria

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

Male-female age between 18 to 64.9 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Marys University

London, TW1 4SX, United Kingdom

Location

Related Publications (1)

  • Podboi ICR, Stephenson S, Pilic L, Graham CA, King A, Mavrommatis Y. Dietary Intake and TCF7L2 rs7903146 T Allele Are Associated with Elevated Blood Glucose Levels in Healthy Individuals. Lifestyle Genom. 2021;14(4):117-123. doi: 10.1159/000518523. Epub 2021 Aug 12.

    PMID: 34515148DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Saliva and blood

MeSH Terms

Conditions

Health BehaviorFeeding BehaviorGenetic Predisposition to Disease

Condition Hierarchy (Ancestors)

BehaviorBehavior, AnimalDisease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2020

First Posted

June 25, 2020

Study Start

April 10, 2019

Primary Completion

September 20, 2019

Study Completion

October 2, 2019

Last Updated

June 25, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)