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Modified Atkins Diet and Type 2 Diabetic Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00552890
First Posted: November 2, 2007
Last Update Posted: November 2, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  Purpose
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 Intervention
Obese Type 2 Diabetic Patients Other: modified Atkins diet Other: ADA recommended diet

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • weight loss and glucose control [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • lipid profile, kidney function [ Time Frame: 1 year ]

Enrollment: 52
Study Start Date: December 2001
Study Completion Date: February 2004
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00552890


Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Itamar Raz, MD Director, Diabetes Unit, Hadassah University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00552890     History of Changes
Other Study ID Numbers: atkins-hmo-ctil
First Submitted: November 1, 2007
First Posted: November 2, 2007
Last Update Posted: November 2, 2007
Last Verified: December 2001

Keywords provided by Hadassah Medical Organization:
obesity
atkins
weight reduction
kidney function