Clinical trial NCT04406402: L-arginine and Asymmetric Dimethylarginine (ADMA) and Lifestyle Protocols
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Obesity
Arginine
Asymmetric Dimethylarginine
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Wolfson Medical Center
First posted: 2020-05-28
Enrollment: 243
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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)

Eligibility criteria: 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).

Primary outcomes:
measure: Serum L-arginine change
timeFrame: 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
measure: High asymmetric dimethylarginine (ADMA) change
timeFrame: 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 outcomes:
measure: Body mass index (BMI) change
timeFrame: From baseline to 12 weeks for lifestyle modification phase
measure: Glycated hemoglobin (HbA1c) change
timeFrame: From baseline to 12 weeks for lifestyle modification phase
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Diabetes Unit, E. Wolfson Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Naftali Stern, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buch A, Ganz T, Wainstein J, Gilad S, Limor R, Shefer G, Boaz M, Stern N. Alcohol Drinks Induce Acute Lowering in Circulating l-Arginine in Obese and Type 2 Diabetic Subjects. J Med Food. 2022 Jun;25(6):675-682. doi: 10.1089/jmf.2021.0045.