Modified Atkins Diet and Type 2 Diabetic Patients | NCT00552890

Studies
Modified Atkins Diet and Type 2 Diabetic Patients

NCT00552890

Sponsor

Hadassah Medical Organization

Status

Completed

Last Update Posted

Nov 2, 2007Estimated

Enrollment

52Actual

Phase

Not Applicable

Conditions

Obese Type 2 Diabetic Patients

Interventions

modified Atkins diet
ADA recommended diet

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2001

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2001

Primary Completion Date

Not provided

Completion Date

Feb 2004Actual

First Submitted Date

Nov 1, 2007

First Submission Date that Met QC Criteria

Nov 1, 2007

First Posted Date

Nov 2, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2007

Last Update Posted Date

Nov 2, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ATK	Experimental	modified Atkins diet	Other: modified Atkins diet
ADA	Experimental	subjects assigned to follow ADA recommended diet for 1 year	Other: ADA recommended diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
modified Atkins diet	Other	subjects assigned to follow modified Atkins diet for 1 year	ATK

Measure	Description	Time Frame
weight loss and glucose control		1 year

Measure	Description	Time Frame
lipid profile, kidney function		1 year

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Itamar Raz, MD	Director, Diabetes Unit, Hadassah University Hospital	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D015431	Weight Loss

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided