NCT01292590

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2010

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 9, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

1 year

First QC Date

October 21, 2010

Last Update Submit

April 25, 2017

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Change in insulin requirements

    postprandially until 8 hours

Study Arms (1)

High fat meal

EXPERIMENTAL
Other: High fat meal

Interventions

High fat mealOTHER

40 grams saturated fat

Also known as: Macronutrient
High fat meal

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 1 diabetes using insulin pump and CGM

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Nutrients

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Howard Wolpert, MD

    Joslin Diabetes Center/Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2010

First Posted

February 9, 2011

Study Start

September 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

April 26, 2017

Record last verified: 2017-04

Locations

US(1)