The TCF7L2 Gene: Dietary Prevention of T2DM

Description

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.

Study Start Date

February, 15 2018

Estimated Completion Date

February 2021

Interventions

  • Other: Mediterranean Diet
  • Other: Low-fat diet

Study ID

Tufts University -- TCF7L2_2965

Status

Unknown

Trial ID

NCT03458494

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

40

Sponsor

Tufts University

Inclusion Criteria

  • Men and women.
  • 18 years or older.
  • Women who are not pregnant.
  • A BMI ranging between 27 and 34

Exclusion Criteria

  • Unexplained elevation in serum transaminases (i.e. >1.5 times the upper limit of normal) or with evidence of active liver disease, including primary biliary cirrhosis or pre-existing gallbladder disease.
  • Severe renal dysfunction (serum creatinine >2.0mg/dL).
  • Excessive alcohol consumption (>2 drinks/day).
  • Preexisting CVD.
  • Stable exertional angina pectoris requiring sublingual nitroglycerin within the prior 3 months.
  • Uncontrolled T2D (fasting glucose >126 mg/dl) or other significant endocrine disease.
  • Uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg).
  • History of pancreatitis within 1 yr. prior to screening.
  • Subjects on lipid-lowering or diabetes medications.
  • Smoking.
  • Pregnancy.
  • Body mass index (BMI) below 27 or greater than 34 kg/m2
  • Participants will also be excluded for drug abuse, extreme dietary habits, multiple food allergies, extreme levels of physical or athletic activity, or by changes in body weight >20 lbs. during the last 6 months.
  • Inability to follow any of the experimental diets or to perform the sampling required for this study.
  • Thyroid diseases.
  • Use of omega-3 supplements (unless it is discontinued one month prior to the beginning of the study).

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
JMUSDA Human Nutrition Research Center on Aging at Tufts University - Boston, Massachusetts 3.2 miles Cheryl H Gilhooly PHD RD 617-556-3154 Cheryl.Gilhooly@tufts.edu

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