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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04406402
• Other study ID #: 03
• Status: Completed
• Phase: N/A
• Start date: December 5, 2006
• Est. completion date: December 10, 2008

Study information

• Verified date: May 2020
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: December 10, 2008
• Est. primary completion date: April 4, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arginine
• Asymmetric Dimethylarginine
• Diabetes Mellitus, Type 2
• Obesity

Intervention

Behavioral:
• Acute dietary protocols and lifestyle modification
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).

Locations

Country	Name	City	State
Israel	Diabetes Unit, E. Wolfson Medical Center	Holon

Sponsors (2)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum L-arginine change	Change in arginine levels (absolute and relative) (µmol/l)	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
Primary	High asymmetric dimethylarginine (ADMA) change	Change in ADMA levels (absolute and relative) (µmol/l)	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	Body mass index (BMI) change	Change in BMI levels (Kg/m2)	From baseline to 12 weeks for lifestyle modification phase
Secondary	Glycated hemoglobin (HbA1c) change	Change in HbA1c levels (%)	From baseline to 12 weeks for lifestyle modification phase