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

Sponsor:	Second University of Naples
Information provided by:	Second University of Naples
ClinicalTrials.gov Identifier:	NCT00725257

Purpose

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%.

Condition	Intervention
Type 2 Diabetes Mellitus	Other: Mediterranean diet Other: Low-fat diet

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effect of a Low-Carbohydrate Mediterranean Diet or Low-Fat Diet in Newly-Diagnosed Type 2 Diabetic Patients

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2 Metabolic Disorders

U.S. FDA Resources

Further study details as provided by Second University of Naples:

Primary Outcome Measures:

Hemoglobin A1c [ Time Frame: Every sixth month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time to introduction of an oral hypoglycemic agent [ Time Frame: Every year ] [ Designated as safety issue: Yes ]

Enrollment:	215
Study Start Date:	June 2004
Study Completion Date:	December 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Low-carbohydrate, energy-restricted, Mediterranean-type diet	Other: 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%.
Active Comparator: 2 Low-fat diet	Other: 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

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00725257

Locations

Italy
Department of Geriatrics and Metabolic Diseases
Naples, Italy, 80138

Sponsors and Collaborators

Second University of Naples

Investigators

Principal Investigator:

Dario Giugliano, MD,PhD

Department of Geriatrics and Metabolic Diseases

More Information

Publications:

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, Blüher 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.

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. No abstract available.

Responsible Party:	Department of Geriatrics and Metabolic Diseases
ClinicalTrials.gov Identifier:	NCT00725257 History of Changes
Other Study ID Numbers:	DGMM/4/2004
Study First Received:	July 28, 2008
Last Updated:	July 28, 2008
Health Authority:	Italy: Ethics Committee

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 09, 2012