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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Obesity; Arginine; Asymmetric Dimethylarginine
• Interventions: Behavioral: Acute dietary protocols and lifestyle modification

• 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

Arm && Interventions

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

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