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The Impact of Food on Blood Sugar in People With Type 2 Diabetes

NCT ID: NCT01237314

Last Updated: 2015-12-02

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

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-05-31

Brief Summary

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This study will record the impact of food on blood glucose levels using continuous glucose monitoring (CGM).

The investigators think the impact will improve as medication doses are adjusted. The investigators also think that the impact will differ depending on the type of medication taken.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Glargine Group

After baseline titration of metformin, this group will take glargine along with metformin.

No interventions assigned to this group

Exenatide Group

After baseline titration of metformin, this group will take exenatide along with metformin.

No interventions assigned to this group

Glargine and Exenatide Group

After baseline titration of metformin, this group will take glargine and exenatide along with metformin.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Study participants who are consented for the primary study and have not yet done the baseline CGM data collection at week -2-0.

Exclusion Criteria

* Study participants who are unable to complete the baseline CGM data collection at week -2-0.
* Study participants who are allergic to or have a food intolerance to any of the foods in the fixed meal
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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International Diabetes Center at Park Nicollet

OTHER

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role collaborator

HealthPartners Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maggie Powers, PhD

Role: PRINCIPAL_INVESTIGATOR

International Diabetes Center at Park Nicollet

Alice Shapiro, PhD

Role: PRINCIPAL_INVESTIGATOR

International Diabetes Center at Park Nicollet

Locations

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International Diabetes Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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04037-10-C

Identifier Type: -

Identifier Source: org_study_id