An interventional study of Acute dietary protocols and lifestyle modification in Diabetes Mellitus, Type 2, Obesity and Arginine, sponsored by Tel-Aviv Sourasky Medical Center. Completed at 1 site in Israel. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2020-06-02.
Sponsored by Tel-Aviv Sourasky Medical Center · Not applicable, Interventional, and Other
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.
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)
9,590 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 243 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Tel-Aviv Sourasky Medical Center is the lead sponsor of 553 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
A standard oral glucose tolerance test (75 grams of dextrose in 180 cc of water)
Behavioral: Acute dietary protocols and lifestyle modification
A protein-rich, vanilla-flavored powder (Pro-gym, Telpharma, Is
Behavioral: Acute dietary protocols and lifestyle modification
a 100-gram portion of sweet cream containing 300 Kacls, of which 94% of the ingested calories were fat
Behavioral: Acute dietary protocols and lifestyle modification
Vodka (100 cc, 40% alcohol)
Behavioral: Acute dietary protocols and lifestyle modification
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.
Behavioral: Acute dietary protocols and lifestyle modification
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.
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).
Serum L-arginine change
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
High asymmetric dimethylarginine (ADMA) change
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
Body mass index (BMI) change
Change in BMI levels (Kg/m2)
Time frame: From baseline to 12 weeks for lifestyle modification phase
Glycated hemoglobin (HbA1c) change
Change in HbA1c levels (%)
Time frame: From baseline to 12 weeks for lifestyle modification phase
Plan to share: No
Ran from Dec 2006 to primary completion in Apr 2008, 15 months.
Of 1,924 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's 15 months is below that.
Counting every sponsor, half of 2,101 studies reached it within 20 months; a quarter within 10 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tel-Aviv Sourasky Medical Center →