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

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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The Effects of Different Acute Nutritional Protocols and Lifestyle Modification on Circulating L-arginine and Asymmetric Dimethylarginine (ADMA) in Obese and Type 2 Diabetic Subjects

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

Intervention / Treatment
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* Behavioral: Acute dietary protocols and lifestyle modification


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acute glucose tolerance test<br>A standard oral glucose tolerance test (75 grams of dextrose in 180 cc of water) | Behavioral: Acute dietary protocols and lifestyle modification<br>* 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).<br>|
| Experimental: Acute protein load test<br>A protein-rich, vanilla-flavored powder (Pro-gym, Telpharma, Is | Behavioral: Acute dietary protocols and lifestyle modification<br>* 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).<br>|
| Experimental: Acute fat load test<br>a 100-gram portion of sweet cream containing 300 Kacls, of which 94% of the ingested calories were fat | Behavioral: Acute dietary protocols and lifestyle modification<br>* 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).<br>|
| Experimental: Acute alcohol load test<br>Vodka (100 cc, 40% alcohol) | Behavioral: Acute dietary protocols and lifestyle modification<br>* 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).<br>|
| Experimental: Acute exercise<br>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. | Behavioral: Acute dietary protocols and lifestyle modification<br>* 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).<br>|
| Experimental: Lifestyle modification program - 12 weeks<br>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. | Behavioral: Acute dietary protocols and lifestyle modification<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum L-arginine change | Change in arginine levels (absolute and relative) (µmol/l) | 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 | 
| High asymmetric dimethylarginine (ADMA) change | Change in ADMA levels (absolute and relative) (µmol/l) | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index (BMI) change | Change in BMI levels (Kg/m2) | From baseline to 12 weeks for lifestyle modification phase | 
| Glycated hemoglobin (HbA1c) change | Change in HbA1c levels (%) | From baseline to 12 weeks for lifestyle modification phase |