Diabetes Mellitus, Type 2NCT04406402
L-arginine and Asymmetric Dimethylarginine (ADMA) and Lifestyle Protocols
A study testing Acute dietary protocols and lifestyle modification in people with Diabetes Mellitus, Type 2 and Obesity, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity, Arginine
- What is being tested?
- Acute dietary protocols and lifestyle modification
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 1 siteIsrael
- Study dates
- 5 Dec 2006to 10 Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- obese and/ or T2DM subjects
Who cannot join
- 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
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- abnormal thyroid function tests
- concomitant or recent use of glucocorticoids
- uncertain mental state (to avoid invalid informed consent or lack of compliance).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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)
- Being tested
- Acute dietary protocols and lifestyle modification
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute dietary protocols and lifestyle modificationBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Acute glucose tolerance test | Experimental | A standard oral glucose tolerance test (75 grams of dextrose in 180 cc of water) Receives: Behavioral: Acute dietary protocols and lifestyle modification |
| Acute protein load test | Experimental | A protein-rich, vanilla-flavored powder (Pro-gym, Telpharma, Is Receives: Behavioral: Acute dietary protocols and lifestyle modification |
| Acute fat load test | Experimental | a 100-gram portion of sweet cream containing 300 Kacls, of which 94% of the ingested calories were fat Receives: Behavioral: Acute dietary protocols and lifestyle modification |
| Acute alcohol load test | Experimental | Vodka (100 cc, 40% alcohol) Receives: Behavioral: Acute dietary protocols and lifestyle modification |
| Acute exercise | Experimental | 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. Receives: Behavioral: Acute dietary protocols and lifestyle modification |
| Lifestyle modification program - 12 weeks | Experimental | 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. Receives: Behavioral: Acute dietary protocols and lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum L-arginine change
Change in arginine levels (absolute and relative) (µmol/l)
Measured: 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)
Measured: 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
Change in BMI levels (Kg/m2)
Measured: From baseline to 12 weeks for lifestyle modification phase
Glycated hemoglobin (HbA1c) change
Change in HbA1c levels (%)
Measured: From baseline to 12 weeks for lifestyle modification phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start5 Dec 2006
- Primary completion4 Apr 2008
- Study completion10 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Wolfson Medical Center
- Responsible party
- Sponsor
- Investigators
- Naftali Stern, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406402
- Sponsor's protocol ID
- 03
- Status last verified
- May 2020
- First submitted
- 25 May 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35708634
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04406402
- Acronym / sponsor ID
- 03
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Wolfson Medical Center
- Study start
- 5 Dec 2006 (actual)
- Primary completion
- 4 Apr 2008 (actual)
- Study completion
- 10 Dec 2008 (actual)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Acute glucose tolerance test | Experimental | Behavioral: Acute dietary protocols and lifestyle modificationA standard oral glucose tolerance test (75 grams of dextrose in 180 cc of water) |
| Acute protein load test | Experimental | Behavioral: Acute dietary protocols and lifestyle modificationA protein-rich, vanilla-flavored powder (Pro-gym, Telpharma, Is |
| Acute fat load test | Experimental | Behavioral: Acute dietary protocols and lifestyle modificationa 100-gram portion of sweet cream containing 300 Kacls, of which 94% of the ingested calories were fat |
| Acute alcohol load test | Experimental | Behavioral: Acute dietary protocols and lifestyle modificationVodka (100 cc, 40% alcohol) |
| Acute exercise | Experimental | Behavioral: Acute dietary protocols and lifestyle modification30 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 | Experimental | Behavioral: Acute dietary protocols and lifestyle modification12 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- obese and/ or T2DM subjects
Key exclusion criteria (9 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute dietary protocols and lifestyle modificationThe 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). | Behavioural | Acute alcohol load test, Acute exercise, Acute fat load test, Acute glucose tolerance test, Acute protein load test, Lifestyle modification program - 12 weeks |
Primary outcome
Serum L-arginine change
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
Change in arginine levels (absolute and relative) (µmol/l)
High asymmetric dimethylarginine (ADMA) change
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
Change in ADMA levels (absolute and relative) (µmol/l)
2 secondary outcomes
Body mass index (BMI) change
Time frame: From baseline to 12 weeks for lifestyle modification phase
Glycated hemoglobin (HbA1c) change
Time frame: From baseline to 12 weeks for lifestyle modification phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Derived from this study: PubMed 35708634Buch 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naftali Stern, MD principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute dietary protocols and lifestyle modification in people with Diabetes Mellitus, Type 2 and Obesity, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum L-arginine change (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04406402, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.