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

Tel Aviv Sourasky Medical Center

Status: Completed

Conditions: Asymmetric Dimethylarginine; Arginine; Obesity; Diabetes Mellitus, Type 2

Treatments: Behavioral: Acute dietary protocols and lifestyle modification

Study type: Interventional

Funder types: Other

Identifiers

NCT04406402

03

Details and patient eligibility

About

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.

Full description

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)

Enrollment: 243 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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243 participants in 6 patient groups

Acute glucose tolerance test

Experimental group

Description:

A standard oral glucose tolerance test (75 grams of dextrose in 180 cc of water)

Treatment:

Behavioral: Acute dietary protocols and lifestyle modification

Acute protein load test

Experimental group

Description:

A protein-rich, vanilla-flavored powder (Pro-gym, Telpharma, Is

Treatment:

Behavioral: Acute dietary protocols and lifestyle modification

Acute fat load test

Experimental group

Description:

a 100-gram portion of sweet cream containing 300 Kacls, of which 94% of the ingested calories were fat

Treatment:

Behavioral: Acute dietary protocols and lifestyle modification

Acute alcohol load test

Experimental group

Description:

Vodka (100 cc, 40% alcohol)

Treatment:

Behavioral: Acute dietary protocols and lifestyle modification

Acute exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Acute dietary protocols and lifestyle modification

Lifestyle modification program - 12 weeks

Experimental group

Description:

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.

Treatment:

Behavioral: Acute dietary protocols and lifestyle modification