Effect of Dietary Fat on Glycemic Control in Type 1 Diabetes | NCT01292590

Studies
Effect of Dietary Fat on Glycemic Control in Type 1 Diabetes

NCT01292590

Sponsor

Joslin Diabetes Center

Status

Completed

Last Update Posted

Apr 26, 2017Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Type 1 Diabetes

Interventions

High fat meal

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

Apr 2017

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

Sep 2010

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Oct 21, 2010

First Submission Date that Met QC Criteria

Feb 8, 2011

First Posted Date

Feb 9, 2011Estimated

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

Apr 25, 2017

Last Update Posted Date

Apr 26, 2017Actual

Name	Class
Beth Israel Deaconess Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to determine if dietary fat alters insulin requirements in type 1 diabetes.

Detailed Description

This cross-over prospective study will require a two day admission to the clinical research center. Subjects will undergo closed loop glucose control and will received a diet with controlled macronutrient content.

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

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High fat meal	Experimental		Other: High fat meal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High fat meal	Other	40 grams saturated fat	High fat meal	Macronutrient

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in insulin requirements		postprandially until 8 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

type 1 diabetes using insulin pump and CGM

Exclusion Criteria:

renal or hepatic failure
cancer or lymphoma
malabsorption or malnourishment
hypercortisolism
alcoholism or drug abuse
anemia (hematocrit < 36 in females and <40 in males)
eating disorder
dietary restrictions
Acetaminophen allergy
Chronic acetaminophen use
Glucocorticoid therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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
Howard Wolpert, MD	Joslin Diabetes Center/Beth Israel Deaconess Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beth Israel Deaconess Medical Center		Boston	Massachusetts	02215	United States

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

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
D000078622	Nutrients

Ancestor Terms

ID	Term
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages

Browse Leaves

Not provided

Browse Branches

Not provided