Modified Atkins Diet and Type 2 Diabetic Patients

• Sponsor: Hadassah Medical Organization (Other)
• Overall Status: Completed
• CT.gov ID: NCT00552890
• Collaborator: (none)
• Enrollment: 52
• Arms: 2
• Duration (Months): 26

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Obese Type 2 Diabetic Patients	Other: modified Atkins diet; Other: ADA recommended diet	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Influende of a Modified Atkins Diet on Glucose Metabolism and Weight Loss in Obese Type 2 Diabetic Patients - A Randomized Controlled Trial
• Study Start Date: Dec 1, 2001
• Actual Study Completion Date: Feb 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ATK modified Atkins diet	Other: modified Atkins diet; subjects assigned to follow modified Atkins diet for 1 year
Experimental: ADA subjects assigned to follow ADA recommended diet for 1 year	Other: ADA recommended diet; subjects assigned to follow ADA recommended diet for period of 1 year

Outcome Measures

Primary Outcome Measures

1. weight loss and glucose control [1 year]

Secondary Outcome Measures

1. lipid profile, kidney function [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hadassah Medical Organization

Investigators

• Principal Investigator: Itamar Raz, MD, Director, Diabetes Unit, Hadassah University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00552890
• Other Study ID Numbers: atkins-hmo-ctil
• First Posted: Nov 2, 2007
• Last Update Posted: Nov 2, 2007
• Last Verified: Dec 1, 2001

• Keywords provided by , ,: obesity; atkins; weight reduction; kidney function

Study Results

No Results Posted as of Nov 2, 2007