L-arginine and Asymmetric Dimethylarginine (ADMA) and Lifestyle Protocols
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
1 other identifier
interventional
243
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Dec 2006
Typical duration for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 5, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2008
CompletedFirst Submitted
Initial submission to the registry
May 25, 2020
CompletedFirst Posted
Study publicly available on registry
May 28, 2020
CompletedJune 2, 2020
May 1, 2020
1.3 years
May 25, 2020
May 30, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (2)
Body mass index (BMI) change
From baseline to 12 weeks for lifestyle modification phase
Glycated hemoglobin (HbA1c) change
From baseline to 12 weeks for lifestyle modification phase
Study Arms (6)
Acute glucose tolerance test
EXPERIMENTALA standard oral glucose tolerance test (75 grams of dextrose in 180 cc of water)
Acute protein load test
EXPERIMENTALA protein-rich, vanilla-flavored powder (Pro-gym, Telpharma, Is
Acute fat load test
EXPERIMENTALa 100-gram portion of sweet cream containing 300 Kacls, of which 94% of the ingested calories were fat
Acute alcohol load test
EXPERIMENTALVodka (100 cc, 40% alcohol)
Acute exercise
EXPERIMENTAL30 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
EXPERIMENTAL12 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- obese and/ or T2DM subjects
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tel-Aviv Sourasky Medical Centerlead
- Wolfson Medical Centercollaborator
Study Sites (1)
Diabetes Unit, E. Wolfson Medical Center
Holon, 5822012, Israel
Related Publications (1)
Buch A, Ganz T, Wainstein J, Gilad S, Limor R, Shefer G, Boaz M, Stern N. Alcohol Drinks Induce Acute Lowering in Circulating l-Arginine in Obese and Type 2 Diabetic Subjects. J Med Food. 2022 Jun;25(6):675-682. doi: 10.1089/jmf.2021.0045.
PMID: 35708634DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Naftali Stern, MD
Tel-Aviv Sourasky Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2020
First Posted
May 28, 2020
Study Start
December 5, 2006
Primary Completion
April 4, 2008
Study Completion
December 10, 2008
Last Updated
June 2, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share