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Modified Atkins Diet and Type 2 Diabetic Patients

NCT ID: NCT00552890

Last Updated: 2007-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2004-02-29

Brief Summary

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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

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Conditions

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Obese Type 2 Diabetic Patients

Keywords

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obesity atkins weight reduction kidney function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ATK

modified Atkins diet

Group Type EXPERIMENTAL

modified Atkins diet

Intervention Type OTHER

subjects assigned to follow modified Atkins diet for 1 year

ADA

subjects assigned to follow ADA recommended diet for 1 year

Group Type EXPERIMENTAL

ADA recommended diet

Intervention Type OTHER

subjects assigned to follow ADA recommended diet for period of 1 year

Interventions

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modified Atkins diet

subjects assigned to follow modified Atkins diet for 1 year

Intervention Type OTHER

ADA recommended diet

subjects assigned to follow ADA recommended diet for period of 1 year

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Principal Investigators

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Itamar Raz, MD

Role: PRINCIPAL_INVESTIGATOR

Director, Diabetes Unit, Hadassah University Hospital

Other Identifiers

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atkins-hmo-ctil

Identifier Type: -

Identifier Source: org_study_id