L-arginine and Asymmetric Dimethylarginine (ADMA) and Lifestyle Protocols
NCT ID: NCT04406402
Last Updated: 2020-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
243 participants
INTERVENTIONAL
2006-12-05
2008-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
SINGLE
Study Groups
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Acute glucose tolerance test
A standard oral glucose tolerance test (75 grams of dextrose in 180 cc of water)
Acute dietary protocols and lifestyle modification
The investigators tested the effects on serum Arg and ADMA of a) a single load of ingested dextrose, protein, fat or alcohol, each consumed within 10 minutes; b) a single episode of physical exercise; c) a 12 weeks lifestyle modification program comprised of a standard dietary and physical activity counseling in obese or T2DM subjects on circulating Arg and ADMA (n=43).
Acute protein load test
A protein-rich, vanilla-flavored powder (Pro-gym, Telpharma, Is
Acute dietary protocols and lifestyle modification
The investigators tested the effects on serum Arg and ADMA of a) a single load of ingested dextrose, protein, fat or alcohol, each consumed within 10 minutes; b) a single episode of physical exercise; c) a 12 weeks lifestyle modification program comprised of a standard dietary and physical activity counseling in obese or T2DM subjects on circulating Arg and ADMA (n=43).
Acute fat load test
a 100-gram portion of sweet cream containing 300 Kacls, of which 94% of the ingested calories were fat
Acute dietary protocols and lifestyle modification
The investigators tested the effects on serum Arg and ADMA of a) a single load of ingested dextrose, protein, fat or alcohol, each consumed within 10 minutes; b) a single episode of physical exercise; c) a 12 weeks lifestyle modification program comprised of a standard dietary and physical activity counseling in obese or T2DM subjects on circulating Arg and ADMA (n=43).
Acute alcohol load test
Vodka (100 cc, 40% alcohol)
Acute dietary protocols and lifestyle modification
The investigators tested the effects on serum Arg and ADMA of a) a single load of ingested dextrose, protein, fat or alcohol, each consumed within 10 minutes; b) a single episode of physical exercise; c) a 12 weeks lifestyle modification program comprised of a standard dietary and physical activity counseling in obese or T2DM subjects on circulating Arg and ADMA (n=43).
Acute exercise
30 minutes of supervised graded walking on a treadmill according to each subject's individual ability. A goal heart rate was calculated as 70% of the age-adjusted maximal allowable heart rate.
Acute dietary protocols and lifestyle modification
The investigators tested the effects on serum Arg and ADMA of a) a single load of ingested dextrose, protein, fat or alcohol, each consumed within 10 minutes; b) a single episode of physical exercise; c) a 12 weeks lifestyle modification program comprised of a standard dietary and physical activity counseling in obese or T2DM subjects on circulating Arg and ADMA (n=43).
Lifestyle modification program - 12 weeks
12 weeks of weight-loss dietary program constructed according to the guidelines of the American Diabetes Association. Based on weight, gender, and age, daily dietary allowance varied at 1200-1800 Kcal, 50% carbohydrates, 20% protein, and 30% fat. Participants were also asked to engage in moderate physical activity comprised of a 40-minute walk three times a week. A weekly clinic visit alternating with a weekly telephone contact was also required.
Acute dietary protocols and lifestyle modification
The investigators tested the effects on serum Arg and ADMA of a) a single load of ingested dextrose, protein, fat or alcohol, each consumed within 10 minutes; b) a single episode of physical exercise; c) a 12 weeks lifestyle modification program comprised of a standard dietary and physical activity counseling in obese or T2DM subjects on circulating Arg and ADMA (n=43).
Interventions
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Acute dietary protocols and lifestyle modification
The investigators tested the effects on serum Arg and ADMA of a) a single load of ingested dextrose, protein, fat or alcohol, each consumed within 10 minutes; b) a single episode of physical exercise; c) a 12 weeks lifestyle modification program comprised of a standard dietary and physical activity counseling in obese or T2DM subjects on circulating Arg and ADMA (n=43).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* insulin-treated T2DM
* active coronary disease (recent \[≤ 6months\] myocardial infarction, unstable angina, recent coronary catheterization, or coronary bypass grafting
* individuals with significant impairment in liver enzymes (≥ 2.5 the upper limit of the normal range)
* serum creatinine higher than 1.5mg%
* known malabsorption, alcoholism or illicit use of drugs
* abnormal thyroid function tests
* concomitant or recent use of glucocorticoids
* uncertain mental state (to avoid invalid informed consent or lack of compliance).
40 Years
ALL
No
Sponsors
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Wolfson Medical Center
OTHER_GOV
Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Naftali Stern, MD
Role: PRINCIPAL_INVESTIGATOR
Tel-Aviv Sourasky Medical Center
Locations
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Diabetes Unit, E. Wolfson Medical Center
Holon, , Israel
Countries
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References
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Buch A, Ganz T, Wainstein J, Gilad S, Limor R, Shefer G, Boaz M, Stern N. Alcohol Drinks Induce Acute Lowering in Circulating l-Arginine in Obese and Type 2 Diabetic Subjects. J Med Food. 2022 Jun;25(6):675-682. doi: 10.1089/jmf.2021.0045.
Other Identifiers
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03
Identifier Type: -
Identifier Source: org_study_id
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