NCT04406402 - L-arginine and Asymmetric Dimethylarginine (ADMA) and Lifestyle Protocols | Crick

Overview

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.

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)

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

243

Conditions

Diabetes Mellitus, Type 2 Obesity Arginine Asymmetric Dimethylarginine

Interventions

Acute dietary protocols and lifestyle modificationBEHAVIORAL

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

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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).

Locations (1)

Diabetes Unit, E. Wolfson Medical Center

Holon, Israel

Outcomes

Primary Outcomes

Serum L-arginine change

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

Time frame: 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)

Time frame: 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

Body mass index (BMI) change

Change in BMI levels (Kg/m2)

Time frame: From baseline to 12 weeks for lifestyle modification phase

Glycated hemoglobin (HbA1c) change

Change in HbA1c levels (%)

Time frame: From baseline to 12 weeks for lifestyle modification phase