Dietary Control of Type 2 Diabetes: Low-Carbohydrate Mediterranean Diet Versus Low-Fat Diet

NCT00725257 | Completed

• 1 other identifier: DGMM/4/2004
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

Brief Summary

The major environmental factors that increase the risk of type 2 diabetes, presumably in the setting of genetic risk, are overnutrition and a sedentary lifestyle, with consequent overweight and obesity. The high rate of weight regain has limited the role of lifestyle interventions as an effective means of controlling glycemia long term. The aims of the present study were: 1) To compare the effectiveness and safety of two nutritional protocols - namely low-carbohydrate Mediterranean diet or low-fat diet - in newly-diagnosed, drug-naive overweight patients with type 2 diabetes mellitus. The primary aim of the study was the effect on hemoglobin A1c levels; secondary aims were time to introduction of the first hypoglycemic agent, prevalence of the metabolic syndrome, percentage of patients meeting ADA goals for risk factors (HbA1c, blood pressure, LDL-cholesterol, percentage of patients with HbA1c \< 7%.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c

  Every sixth month

Secondary Outcomes (1)

• Time to introduction of an oral hypoglycemic agent

  Every year

Study Arms (2)

1

ACTIVE COMPARATOR

Low-carbohydrate, energy-restricted, Mediterranean-type diet

Other: Mediterranean diet

2

ACTIVE COMPARATOR

Low-fat diet

Other: Low-fat diet

Interventions

Mediterranean diet OTHER

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%.

1

Low-fat diet OTHER

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%.

2

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes mellitus (ADA 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.

You may not qualify if:

• Pregnancy or breast-feeding
• 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.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Department of Geriatrics and Metabolic Diseases

Naples, 80138, Italy

Location

Related Publications (7)

• 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.

  PMID: 18635428 BACKGROUND

• 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.

  PMID: 17301311 BACKGROUND

• 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.

  PMID: 27798369 DERIVED

• 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.

  PMID: 27614727 DERIVED

• 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.

  PMID: 27352954 DERIVED

• 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.

  PMID: 26740638 DERIVED

• 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.

  PMID: 24722497 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet, Mediterranean; Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Dario Giugliano, MD,PhD

  Department of Geriatrics and Metabolic Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: July 30, 2008
• Study Start: June 1, 2004
• Primary Completion: September 1, 2007
• Study Completion: December 1, 2007
• Last Updated: July 30, 2008

Record last verified: 2008-07

Locations

IT (1)