Status:
COMPLETED
Dietary Intake of Tryptophan and Metformin Response
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Metformin Response
Fasting Glucose
Eligibility:
All Genders
20-40 years
Phase:
EARLY_PHASE1
Brief Summary
This study will examine the influence of dietary intake of tryptophan on response to metformin. The investigators hypothesize that dietary tryptophan alteration will influence metformin response.
Eligibility Criteria
Inclusion
- healthy adult male or non-pregnant female volunteers (age 20-40)
- able and willing to give consent
Exclusion
- Age less than 20 or greater than 40
- Women who are pregnant, nursing, or at risk of becoming pregnant
- Body mass index (BMI) less than 20 or greater than 28
- Changes of more than 5 pounds in weight (increase or decrease) during the month prior to enrollment in the study
- Participation in more than 300 minutes of exercise per week during the month prior to enrollment in the study
- Known diabetes or pre-diabetes (based on prior diagnoses, use of medications to lower glucose; or fasting blood glucose \> 100mg/dL at screening)
- Untreated hypertension (defined as systolic blood pressure \> 140mmHg and diastolic blood pressure \> 90mmHg)
- Current or past mood disorder, including major depression, anxiety, or bipolar disorder
- Conditions causing intestinal malabsorption, including celiac disease or a history of intestinal or gastric bypass surgery
- History of liver disease and/or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 3 times upper limit of normal (ULN)
- Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation
- Currently taking or intending to take during the study duration any medication known to affect glycemic parameters, such as glucocorticoids, growth hormone, or fluoroquinolones
- Use of medications and herbal or vitamin supplements during the study
- Contraindications to safe use of metformin, including planned radiologic or angiographic study requiring contrast within one week of the study completion
- Objection to taking metformin
- Participation in any other interventional study during the study duration
- Use of nicotine-containing products, including inhaled, chewed, or patches during the study.
- Use of drugs of abuse.
- Restrictions that prevent adherence to standardized meals or unwillingness to adhere to a pre-specified meal plan, including abstinence from alcohol and limitation of caffeine intake to one drink daily.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02184832
Start Date
August 1 2014
End Date
March 1 2016
Last Update
March 16 2016
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114