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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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:

U.S. FDA Resources

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

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00552890

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

No publications provided

ClinicalTrials.gov Identifier: NCT00552890     History of Changes
Other Study ID Numbers: atkins-hmo-ctil
Study First Received: November 1, 2007
Last Updated: November 1, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on May 21, 2013