Status:
TERMINATED
The TCF7L2 Gene: Dietary Prevention of T2DM
Lead Sponsor:
Tufts University
Collaborating Sponsors:
Allen Foundation Inc.
Conditions:
Type2 Diabetes
Glucose, High Blood
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 fro...
Detailed Description
Type 2 diabetes (T2DM) is associated with increased morbidity and mortality, and its growing prevalence represents a major public health concern. T2D results from a combination of genetics and the exp...
Eligibility Criteria
Inclusion
- Men and women.
- 18 years or older.
- Women who are not pregnant.
- A BMI ranging between 27 and 34
Exclusion
- 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).
Key Trial Info
Start Date :
February 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2020
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03458494
Start Date
February 15 2018
End Date
April 30 2020
Last Update
September 4 2024
Active Locations (1)
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1
JM-USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111