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

Not Applicable

Completed

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

• Registration Number: NCT04406402
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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)

Study Timeline

• Study Start: 2006-12-05
• Primary Completion: 2008-04-04
• Study Completion: 2008-12-10
• Status Verified: 2020-05
• Study First Submitted: 2020-05-25
• Study First Submitted QC: 2020-05-25
• Study First Posted: 2020-05-28
• Last Update Submitted: 2020-05-30
• Last Update Posted: 2020-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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)
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)

Secondary Outcome Measures

Name	Time	Method
Glycated hemoglobin (HbA1c) change	From baseline to 12 weeks for lifestyle modification phase	Change in HbA1c levels (%)
Body mass index (BMI) change	From baseline to 12 weeks for lifestyle modification phase	Change in BMI levels (Kg/m2)

Trial Locations

Locations (1)

Diabetes Unit, E. Wolfson Medical Center; 🇮🇱 Holon, Israel