Modified Atkins Diet and Type 2 Diabetic Patients

This study has been completed.

Sponsor:

Information provided by:

Hadassah Medical Organization

ClinicalTrials.gov Identifier:

NCT00552890

First received: November 1, 2007

Last updated: NA

Last verified: December 2001

History: No changes posted

Tracking Information

First Received Date ^ICMJE

November 1, 2007

Last Updated Date

November 1, 2007

Start Date ^ICMJE

December 2001

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

weight loss and glucose control [ Time Frame: 1 year ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

lipid profile, kidney function [ Time Frame: 1 year ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Modified Atkins Diet and Type 2 Diabetic Patients

Official Title ^ICMJE

Influende of a Modified Atkins Diet on Glucose Metabolism and Weight Loss in Obese Type 2 Diabetic Patients - A Randomized Controlled Trial

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Obese Type 2 Diabetic Patients

Intervention ^ICMJE

Other: modified Atkins diet
subjects assigned to follow modified Atkins diet for 1 year
Other: ADA recommended diet
subjects assigned to follow ADA recommended diet for period of 1 year

Study Arm (s)

Experimental: ATK
modified Atkins diet

Intervention: Other: modified Atkins diet
Experimental: ADA
subjects assigned to follow ADA recommended diet for 1 year

Intervention: Other: ADA recommended diet

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2004

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

35 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00552890

Other Study ID Numbers ^ICMJE

atkins-hmo-ctil

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Hadassah Medical Organization

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Itamar Raz, MD

Director, Diabetes Unit, Hadassah University Hospital

Information Provided By

Hadassah Medical Organization

Verification Date

December 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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