Modified Atkins Diet and Type 2 Diabetic Patients

November 1, 2007 updated by: Hadassah Medical Organization

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
weight loss and glucose control
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
lipid profile, kidney function
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

November 1, 2007

First Submitted That Met QC Criteria

November 1, 2007

First Posted (Estimate)

November 2, 2007

Study Record Updates

Last Update Posted (Estimate)

November 2, 2007

Last Update Submitted That Met QC Criteria

November 1, 2007

Last Verified

December 1, 2001

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • atkins-hmo-ctil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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