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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Mediterranean diet

Low-fat diet

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Department of Geriatrics and Metabolic Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

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

Low-fat diet

Outcomes

Primary Outcome Measures

Hemoglobin A1c

Secondary Outcome Measures

Time to introduction of an oral hypoglycemic agent

Full Information

NCT ID

NCT00725257

First Posted

July 28, 2008

Last Updated

July 28, 2008

Sponsor

University of Campania "Luigi Vanvitelli"

1. Study Identification

Unique Protocol Identification Number

NCT00725257

Brief Title

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

Official Title

Effect of a Low-Carbohydrate Mediterranean Diet or Low-Fat Diet in Newly-Diagnosed Type 2 Diabetic Patients

Study Type

Interventional

2. Study Status

Record Verification Date

July 2008

Overall Recruitment Status

Completed

Study Start Date

June 2004 (undefined)

Primary Completion Date

September 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Campania "Luigi Vanvitelli"

4. Oversight

Data Monitoring Committee

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

215 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

Low-fat diet

Intervention Type

Other

Intervention Name(s)

Mediterranean diet

Intervention Description

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%.

Intervention Type

Other

Intervention Name(s)

Low-fat diet

Intervention Description

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%.

Primary Outcome Measure Information:

Title

Hemoglobin A1c

Time Frame

Every sixth month

Secondary Outcome Measure Information:

Title

Time to introduction of an oral hypoglycemic agent

Time Frame

Every year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dario Giugliano, MD,PhD

Organizational Affiliation

Department of Geriatrics and Metabolic Diseases

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Geriatrics and Metabolic Diseases

City

Naples

ZIP/Postal Code

80138

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

18635428

Citation

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. Erratum In: N Engl J Med. 2009 Dec 31;361(27):2681.

Results Reference

background

PubMed Identifier

17301311

Citation

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.

Results Reference

background

PubMed Identifier

27798369

Citation

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.

Results Reference

derived

PubMed Identifier

27614727

Citation

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.

Results Reference

derived

PubMed Identifier

27352954

Citation

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.

Results Reference

derived

PubMed Identifier

26740638

Citation

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.

Results Reference

derived

PubMed Identifier

24722497

Citation

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.

Results Reference

derived

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

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