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

Type 2 Diabetes Clinical Trial

— REACT2  

Official title:

Evaluation of the Glycemic Impact of Food in Patients With Type 2 Diabetes Taking Glargine and/or Exenatide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01237314
• Other study ID #: 04037-10-C
• Status: Completed
• Phase: N/A
• First received: November 5, 2010
• Last updated: November 30, 2015
• Start date: November 2010
• Est. completion date: May 2013

Study information

• Verified date: April 2013
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Locations

Country	Name	City	State
United States	International Diabetes Center	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
HealthPartners Institute	International Diabetes Center at Park Nicollet, Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	4-hour glycemic response at 3 time points	The four-hour glycemic response includes: four-hour post-meal area under the median interstitial glucose curve, post-meal interstitial glucose peak, time to peak, time to return to pre-prandial level (to within 10% of baseline with a maximum of the 4-hour post-meal fast), difference between peak and baseline, average rate of change in interstitial glucose across the 4 hour post-meal period, and percent of the 4-hour post-meal glucose readings >180 mg/dL.	4 hours	No