Lifestyle Modification for Obesity-Related Type 2 Diabetes | NCT00415688

Studies
Lifestyle Modification for Obesity-Related Type 2 Diabetes

NCT00415688

Sponsor

Robert C. Atkins Foundation

Status

Completed

Last Update Posted

Dec 25, 2006Estimated

Enrollment

Phase

Phase 4

Conditions

Type 2 Diabetes Mellitus
Overweight
Obesity

Interventions

Low carbohydrate, ketogenic diet
Low glycemic index, reduced calorie diet

Countries

United States

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 2006

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

Jul 2004

Primary Completion Date

Not provided

Completion Date

Jan 2006

First Submitted Date

Dec 21, 2006

First Submission Date that Met QC Criteria

Dec 21, 2006

First Posted Date

Dec 25, 2006Estimated

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

Dec 21, 2006

Last Update Posted Date

Dec 25, 2006Estimated

Description Module

Brief Summary

Dietary carbohydrate is the major determinant of postprandial glucose levels, and preliminary evidence suggests that low carbohydrate diets improve glycemic control when accompanied by weight loss. To determine if glycemic control can be improved by varying dietary carbohydrate during weight loss, we compared two weight loss diets with different carbohydrate levels for the treatment of obesity-related type 2 diabetes over 24 weeks in the outpatient setting.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Measure	Description	Time Frame
Hemoglobin A1c

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

type 2 diabetes mellitus for at least one year
hgba1c > 6.0
BMI from 27-50 kg/m2

Exclusion Criteria:

Unstable medical condition
Serious medical condition
AST or ALT > 100
Serum creatinine > 1.5

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 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
Eric C Westman, MD MHS	Duke Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duke University Health System		Durham	North Carolina	27704	United States

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D050177	Overweight
D009765	Obesity
D015431	Weight Loss
D006943	Hyperglycemia

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D055423	Diet, Ketogenic

Ancestor Terms

ID	Term
D050528	Diet, Carbohydrate-Restricted
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Low carbohydrate, ketogenic diet	Behavioral
Low glycemic index, reduced calorie diet	Behavioral