Arginine, Asymmetric Dimethylarginine, Diabetes Mellitus, Type 2, Obesity
Conditions
Brief summary
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
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
BEHAVIORALAcute 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).
Sponsors
Wolfson Medical Center
Tel-Aviv Sourasky Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body mass index (BMI) change | From baseline to 12 weeks for lifestyle modification phase | Change in BMI levels (Kg/m2) |
| Glycated hemoglobin (HbA1c) change | From baseline to 12 weeks for lifestyle modification phase | Change in HbA1c levels (%) |
Countries
Israel
Outcome results
None listed