Status:
COMPLETED
Modulating Glucose Tolerance With Dietary Tyrosine
Lead Sponsor:
Columbia University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Glucose Tolerance
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Metabolic or Bariatric surgery is an effective treatment for type 2 diabetes mellitus (T2DM) diabetes associated with obesity. There remain some questions about the biochemical mechanism that drive ho...
Detailed Description
Several biochemical mechanisms explaining how Roux-en-Y Gastric Bypass (RYGB) provides an effective treatment for obesity associated type 2 diabetes mellitus (T2DM) and improves hyperglycemia independ...
Eligibility Criteria
Inclusion
- i. Inclusion Criteria
- Capable of giving written as well as oral informed consent.
- A fasting plasma glucose level (FPG) \< 126 mg/dL (\< 7.0 mmol/L) and an Hb1ac in the 5.7-6.4 % range.
- BMI in the range of 18-45 kg/m2.
- Normal Complete blood count (CBC), renal and liver function tests.
- ii. Exclusion Criteria:
- Any diabetes medication within previous three (3) months.
- Fasting plasma Glucose (FPG) \>126 mg/dl or HbA1c \> 6.4%
- Current use (or within 6 months) of antipsychotic, anti-anxiety, or antidepressant medications (e.g. monoamine oxidase (MAO) inhibitors, 5-Hydroxytryptophan (5HT) inhibitors, tricyclic antidepressants, L-DOPA), reserpine, β-2-receptor agonists (e.g., terbutaline), steroids, weight loss medication, anticoagulant medication, over-the-counter nutritional supplements other than standard vitamin and mineral supplements
- History of Phenylketonuria or other inherited disorders of amino acid metabolism.
- History of movement disorder such as Parkinson's disease or Huntington's disease
- Cardiovascular, renal, pulmonary, gastrointestinal, migraines or other medical conditions deemed significant by investigators
- History of/ or psychiatric illness such as major depression, bipolar disease, anxiety or schizophrenia.
- History of bariatric surgery with the exception of gastric band if the band has been removed
- Female of child-bearing age, currently pregnant, breastfeeding or not using a form of birth control.
- Previous or current use of cocaine, methamphetamine, ecstasy (3-4 methylenedioxymethamphetamine (MDMA))
- Current daily intake of caffeine \>500 mg/day (\>4-5 cups of coffee; \>10 12-oz cans of soda)
- Consumption of more than 1 alcoholic drink per day or smoking more than 5 cigarettes/day.
- Systolic Blood Pressure (SBP) \> 150 mmHg; Diastolic Blood Pressure (DBP) \> 100 mmHg.
- Recent history (in the past three months) of more than a 3% gain or loss in body wt.
- Difficulty in swallowing capsules.
- Concurrent use of antacids or proton pump inhibitors (e.g.,Prilosec Prevacid, dexilant, Aciphex, Protonix, Nexium, Vimovo, Zegerid)
Exclusion
Key Trial Info
Start Date :
August 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03872557
Start Date
August 7 2019
End Date
January 24 2020
Last Update
May 5 2021
Active Locations (1)
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1
Columbia University Irving Medical Center
New York, New York, United States, 10032