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L-arginine and Asymmetric Dimethylarginine (ADMA) and Lifestyle Protocols

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StatusDovršeno
Sponzori
Tel-Aviv Sourasky Medical Center
Suradnici
Wolfson Medical Center

Ključne riječi

Sažetak

Low serum L-arginine (Arg) and high asymmetric dimethylarginine (ADMA) can predict microvascular complications in type 2 diabetes (T2DM). The investigators examined whether or not Arg and ADMA are affected by dietary factors or lifestyle modification in overweight/ obese and T2DM subjects.

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

Diabetes Mellitus, Type 2
Obesity
Arginine
Asymmetric Dimethylarginine

Intervencija / liječenje

Behavioral: Acute dietary protocols and lifestyle modification

Faza

-

Grupe ruku

RukaIntervencija / 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 studijAll
Prihvaća zdrave volontereDa
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]

Change in arginine levels (absolute and relative) (µmol/l)

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]

Change in ADMA levels (absolute and relative) (µmol/l)

Sekundarne mjere ishoda

1. Body mass index (BMI) change [From baseline to 12 weeks for lifestyle modification phase]

Change in BMI levels (Kg/m2)

2. Glycated hemoglobin (HbA1c) change [From baseline to 12 weeks for lifestyle modification phase]

Change in HbA1c levels (%)

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