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NCT03458494 · ClinicalTrials.gov registry record · NA

The TCF7L2 Gene: Dietary Prevention of T2DM

A NA study, sponsored by Tufts University.

Terminated
Registry status
NA
Development phase
37
Enrollment target

NCT03458494: Clinical Trial NA study, sponsored by Tufts University.

NCT03458494 is a NA study that was terminated before completion, run by Tufts University. The registered enrollment target is 37 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03458494, a NA study, was terminated before completion, sponsored by Tufts University.

TERMINATED
Registry status
NA
Development phase
37 participants
Enrollment target

Study Summary

Nutrients and chemicals in food are able to regulate expression of genetic elements. Gene-nutrient interaction in response specific diets can increase an individual's risk, shifting the individual from health toward the development of chronic disease. The Transcription Factor 7 Like 2 (TCF7L2) gene may either put individuals at risk for or protect from Type 2 diabetes mellitus in the presence of certain foods. The main purpose of this four-week study is to examine diet-induced gene-nutrient interaction, with a focus on glucose, insulin, inflammation (CRP) and the plasma metabolome in individuals who have either the CC or the TT form of the rs7903146 single nucleotide polymorphism (SNP) (C/T) within the TCF7L2 gene. The (2) one-week study diets, one Mediterranean diet (MedDiet) based and the other low-fat based will be separated by a (1) week return to a regular habitual diet.

Primary Outcome

Plasma glucose levels (mg/dl) will be measured in the fasting state during each one of the intervention phases (the Mediterranean and low-fat diets) in participants with the TT and CC genotypes at the TCF7L2 rs7903146 SNP

Interventions

  • OTHER Mediterranean Diet
  • OTHER Low-fat diet

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2018-02-15
Est. Completion 2020-04-30
Phase NA
Tufts University

163 total trials

Why NCT03458494 stopped before completion

NCT03458494 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which Mediterranean Diet is the first listed.

NCT03458494 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03458494 about?

NCT03458494 is a clinical study titled "The TCF7L2 Gene: Dietary Prevention of T2DM". Nutrients and chemicals in food are able to regulate expression of genetic elements. Gene-nutrient interaction in response specific diets can increase an individual's risk, shifting the individual from health toward the development of chronic disease. The Transcription Factor 7 Like 2 (TCF7L2) gene ...

What is the current status of trial NCT03458494?

This trial is currently terminated. It is a NA study. The enrollment target is 37 participants. The study started on 2018-02-15. Estimated completion is 2020-04-30.

What interventions are being tested in trial NCT03458494?

The interventions under investigation include: Mediterranean Diet (OTHER), Low-fat diet (OTHER).

Who is sponsoring clinical trial NCT03458494?

This trial is sponsored by Tufts University, which has 163 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03458494's enrollment target sits among peer trials

37 1540th of 2000 higher than 460 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03458494, the US trial registry maintained by the National Library of Medicine. NCT03458494 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.