Modified Atkins Diet and Type 2 Diabetic Patients

Not Applicable

Completed

• Conditions: Obese Type 2 Diabetic Patients
• Interventions: Other: modified Atkins diet; Other: ADA recommended diet

• Registration Number: NCT00552890
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

This randomized control trial compared the influence of an Atkins diet to that of the ADA recommended diet on Type 2 diabetic obese patients during a one-year follow-up period

Detailed Description

Not available

Study Timeline

• Status Verified: 2001-12
• Study Start: 2001-12
• Study Completion: 2004-02
• Study First Submitted: 2007-11-01
• Study First Submitted QC: 2007-11-01
• Last Update Submitted: 2007-11-01
• Study First Posted: 2007-11-02
• Last Update Posted: 2007-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Type 2 diabetic patients age 35-75 years
• BMI 30-39.9kg/m
• HbA1C>7%
• Not receiving insulin
• Micro-albumin excretion<60 mg/day

Exclusion Criteria

• Serum creatinine level > 1.4 mg per deciliter
• Diastolic blood pressure > 100 mmHg or systolic blood pressure > 180mmHg
• Liver disease
• LDL cholesterol > 160 mg per deciliter despite lipid-lowering treatment
• Use of psychiatric medications
• Osteoporosis
• Cancer
• Food allergies, and
• Low carbohydrate diet in the past 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ATK	modified Atkins diet	modified Atkins diet
ADA	ADA recommended diet	subjects assigned to follow ADA recommended diet for 1 year

Primary Outcome Measures

Name	Time	Method
weight loss and glucose control	1 year

Secondary Outcome Measures

Name	Time	Method
lipid profile, kidney function	1 year