L-arginine and Asymmetric Dimethylarginine (ADMA) and Lifestyle Protocols
Ključne riječi
Sažetak
Opis
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)
Datumi
Posljednja provjera: | 04/30/2020 |
Prvo podneseno: | 05/24/2020 |
Predviđena prijava poslana: | 05/24/2020 |
Prvo objavljeno: | 05/27/2020 |
Posljednje ažuriranje poslano: | 05/29/2020 |
Posljednje ažuriranje objavljeno: | 06/01/2020 |
Stvarni datum početka studija: | 12/04/2006 |
Procijenjeni datum primarnog završetka: | 04/03/2008 |
Procijenjeni datum završetka studije: | 12/09/2008 |
Stanje ili bolest
Intervencija / liječenje
Behavioral: Acute dietary protocols and lifestyle modification
Faza
Grupe ruku
Ruka | Intervencija / liječenje |
---|---|
Experimental: Acute glucose tolerance test A standard oral glucose tolerance test (75 grams of dextrose in 180 cc of water) | |
Experimental: Acute protein load test A protein-rich, vanilla-flavored powder (Pro-gym, Telpharma, Is | |
Experimental: Acute fat load test a 100-gram portion of sweet cream containing 300 Kacls, of which 94% of the ingested calories were fat | |
Experimental: Acute alcohol load test Vodka (100 cc, 40% alcohol) | |
Experimental: 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. | |
Experimental: 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. |
Kriterij prihvatljivosti
Dobni uvjeti za studiranje | 40 Years Do 40 Years |
Spolovi koji ispunjavaju uvjete za studij | All |
Prihvaća zdrave volontere | Da |
Kriteriji | Inclusion Criteria: - obese and/ or T2DM subjects Exclusion Criteria: - type 1 diabetes - 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). |
Ishod
Primarne mjere ishoda
1. Serum L-arginine change [For acute phase: before the nutritional/exercise load (time 0), as well as 30, 60, 90, 120 and 150 minutes after the challenge test. And from baseline to 12 weeks for lifestyle modification phase]
2. High asymmetric dimethylarginine (ADMA) change [For acute phase: before the nutritional/exercise load (time 0), as well as 30, 60, 90, 120 and 150 minutes after the challenge test. And from baseline to 12 weeks for lifestyle modification phase]
Sekundarne mjere ishoda
1. Body mass index (BMI) change [From baseline to 12 weeks for lifestyle modification phase]
2. Glycated hemoglobin (HbA1c) change [From baseline to 12 weeks for lifestyle modification phase]