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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014