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
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 |
Verified date | May 2020 |
Source | Tel-Aviv Sourasky Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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). |
Country | Name | City | State |
---|---|---|---|
Israel | Diabetes Unit, E. Wolfson Medical Center | Holon |
Lead Sponsor | Collaborator |
---|---|
Tel-Aviv Sourasky Medical Center | Wolfson Medical Center |
Israel,
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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