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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04406402
Other study ID # 03
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


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
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