Dietary Control of Type 2 Diabetes: Low-Carbohydrate Mediterranean Diet Versus Low-Fat Diet
NCT ID: NCT00725257
Last Updated: 2008-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
215 participants
INTERVENTIONAL
2004-06-30
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Low-carbohydrate, energy-restricted, Mediterranean-type diet
Mediterranean diet
The recommended composition of the dietary regimen was as follows: Carbohydrate 40 to 50%, protein 15 to 20%; fat 30 to 40%; saturated fat less than 10%.
2
Low-fat diet
Low-fat diet
The recommended composition of the dietary regimen was as follows: Fat less than 30%; carbohydrate 50 to 60%, protein 15 to 20%; saturated fat less than 10%.
Interventions
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Mediterranean diet
The recommended composition of the dietary regimen was as follows: Carbohydrate 40 to 50%, protein 15 to 20%; fat 30 to 40%; saturated fat less than 10%.
Low-fat diet
The recommended composition of the dietary regimen was as follows: Fat less than 30%; carbohydrate 50 to 60%, protein 15 to 20%; saturated fat less than 10%.
Eligibility Criteria
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Inclusion Criteria
* BMI (body mass index) \> 25 kg/M2
* Hemoglobin A1c (HbA1c) \< 11%; Blood pressure \< 160 (systolic) and 100 (diastolic) mm Hg
* Triglyceride levels \< 500 mg/dl.
Exclusion Criteria
* Previous use of insulin or oral antidiabetic drugs
* Investigational drug within the previous 3 months
* Use of agents affecting glycemic control (systemic steroids and weight loss drugs)
* Patients with history of alcohol or illicit drug abuse
* Patients with liver enzymes higher than three times the upper limit of normal
* Serum creatinine \> 1.4 mg/dl.
30 Years
75 Years
ALL
No
Sponsors
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University of Campania Luigi Vanvitelli
OTHER
Responsible Party
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Department of Geriatrics and Metabolic Diseases
Principal Investigators
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Dario Giugliano, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Geriatrics and Metabolic Diseases
Locations
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Department of Geriatrics and Metabolic Diseases
Naples, , Italy
Countries
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References
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Shai I, Schwarzfuchs D, Henkin Y, Shahar DR, Witkow S, Greenberg I, Golan R, Fraser D, Bolotin A, Vardi H, Tangi-Rozental O, Zuk-Ramot R, Sarusi B, Brickner D, Schwartz Z, Sheiner E, Marko R, Katorza E, Thiery J, Fiedler GM, Bluher M, Stumvoll M, Stampfer MJ; Dietary Intervention Randomized Controlled Trial (DIRECT) Group. Weight loss with a low-carbohydrate, Mediterranean, or low-fat diet. N Engl J Med. 2008 Jul 17;359(3):229-41. doi: 10.1056/NEJMoa0708681.
Esposito K, Ciotola M, Giugliano D. Low-carbohydrate diet and coronary heart disease in women. N Engl J Med. 2007 Feb 15;356(7):750; author reply 750-2. doi: 10.1056/NEJMc063464. No abstract available.
Maiorino MI, Bellastella G, Petrizzo M, Gicchino M, Caputo M, Giugliano D, Esposito K. Effect of a Mediterranean diet on endothelial progenitor cells and carotid intima-media thickness in type 2 diabetes: Follow-up of a randomized trial. Eur J Prev Cardiol. 2017 Mar;24(4):399-408. doi: 10.1177/2047487316676133. Epub 2016 Oct 27.
Maiorino MI, Bellastella G, Caputo M, Castaldo F, Improta MR, Giugliano D, Esposito K. Effects of Mediterranean diet on sexual function in people with newly diagnosed type 2 diabetes: The MEDITA trial. J Diabetes Complications. 2016 Nov-Dec;30(8):1519-1524. doi: 10.1016/j.jdiacomp.2016.08.007. Epub 2016 Aug 12.
Maiorino MI, Bellastella G, Chiodini P, Romano O, Scappaticcio L, Giugliano D, Esposito K. Primary Prevention of Sexual Dysfunction With Mediterranean Diet in Type 2 Diabetes: The MEDITA Randomized Trial. Diabetes Care. 2016 Sep;39(9):e143-4. doi: 10.2337/dc16-0910. Epub 2016 Jun 28. No abstract available.
Maiorino MI, Bellastella G, Petrizzo M, Scappaticcio L, Giugliano D, Esposito K. Anti-inflammatory Effect of Mediterranean Diet in Type 2 Diabetes Is Durable: 8-Year Follow-up of a Controlled Trial. Diabetes Care. 2016 Mar;39(3):e44-5. doi: 10.2337/dc15-2356. Epub 2016 Jan 6. No abstract available.
Esposito K, Maiorino MI, Petrizzo M, Bellastella G, Giugliano D. The effects of a Mediterranean diet on the need for diabetes drugs and remission of newly diagnosed type 2 diabetes: follow-up of a randomized trial. Diabetes Care. 2014 Jul;37(7):1824-30. doi: 10.2337/dc13-2899. Epub 2014 Apr 10.
Other Identifiers
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DGMM/4/2004
Identifier Type: -
Identifier Source: org_study_id