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

Primary Purpose

Diabetes Mellitus, Type 2, Obesity, Arginine

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Acute dietary protocols and lifestyle modification
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 2

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Diabetes Unit, E. Wolfson Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Acute glucose tolerance test

Acute protein load test

Acute fat load test

Acute alcohol load test

Acute exercise

Lifestyle modification program - 12 weeks

Arm Description

A standard oral glucose tolerance test (75 grams of dextrose in 180 cc of water)

A protein-rich, vanilla-flavored powder (Pro-gym, Telpharma, Is

a 100-gram portion of sweet cream containing 300 Kacls, of which 94% of the ingested calories were fat

Vodka (100 cc, 40% alcohol)

30 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.

12 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.

Outcomes

Primary Outcome Measures

Serum L-arginine change
Change in arginine levels (absolute and relative) (µmol/l)
High asymmetric dimethylarginine (ADMA) change
Change in ADMA levels (absolute and relative) (µmol/l)

Secondary Outcome Measures

Body mass index (BMI) change
Change in BMI levels (Kg/m2)
Glycated hemoglobin (HbA1c) change
Change in HbA1c levels (%)

Full Information

First Posted
May 25, 2020
Last Updated
May 30, 2020
Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Wolfson Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04406402
Brief Title
L-arginine and Asymmetric Dimethylarginine (ADMA) and Lifestyle Protocols
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
December 5, 2006 (Actual)
Primary Completion Date
April 4, 2008 (Actual)
Study Completion Date
December 10, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Wolfson Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Obesity, Arginine, Asymmetric Dimethylarginine

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
243 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acute glucose tolerance test
Arm Type
Experimental
Arm Description
A standard oral glucose tolerance test (75 grams of dextrose in 180 cc of water)
Arm Title
Acute protein load test
Arm Type
Experimental
Arm Description
A protein-rich, vanilla-flavored powder (Pro-gym, Telpharma, Is
Arm Title
Acute fat load test
Arm Type
Experimental
Arm Description
a 100-gram portion of sweet cream containing 300 Kacls, of which 94% of the ingested calories were fat
Arm Title
Acute alcohol load test
Arm Type
Experimental
Arm Description
Vodka (100 cc, 40% alcohol)
Arm Title
Acute exercise
Arm Type
Experimental
Arm Description
30 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.
Arm Title
Lifestyle modification program - 12 weeks
Arm Type
Experimental
Arm Description
12 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.
Intervention Type
Behavioral
Intervention Name(s)
Acute dietary protocols and lifestyle modification
Intervention 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).
Primary Outcome Measure Information:
Title
Serum L-arginine change
Description
Change in arginine levels (absolute and relative) (µmol/l)
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
Title
High asymmetric dimethylarginine (ADMA) change
Description
Change in ADMA levels (absolute and relative) (µmol/l)
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
Secondary Outcome Measure Information:
Title
Body mass index (BMI) change
Description
Change in BMI levels (Kg/m2)
Time Frame
From baseline to 12 weeks for lifestyle modification phase
Title
Glycated hemoglobin (HbA1c) change
Description
Change in HbA1c levels (%)
Time Frame
From baseline to 12 weeks for lifestyle modification phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naftali Stern, MD
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diabetes Unit, E. Wolfson Medical Center
City
Holon
ZIP/Postal Code
5822012
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35708634
Citation
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.
Results Reference
derived

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

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