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Completed

NCT Number: NCT04406402

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Arginine Asymmetric Dimethylarginine Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes Unit, E. Wolfson Medical Center

Holon, 5822012, Israel

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Acute dietary protocols and lifestyle modification

Behavioral

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).

Primary outcomes

  1. Serum L-arginine change

    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

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

  2. High asymmetric dimethylarginine (ADMA) change

    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

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

Secondary outcomes

  1. Body mass index (BMI) change

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

    Change in BMI levels (Kg/m2)

  2. Glycated hemoglobin (HbA1c) change

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

    Change in HbA1c levels (%)

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Collaborators

  • Wolfson Medical Center

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
May 28, 2020
Registry last updated
Jun 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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