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The Impact of Food on Blood Sugar in People With Type 2 Diabetes (REACT2)

This study has been completed.
Sponsor:
Collaborators:
International Diabetes Center at Park Nicollet
Sanofi
Information provided by (Responsible Party):
Park Nicollet Institute
ClinicalTrials.gov Identifier:
NCT01237314
First received: November 5, 2010
Last updated: October 9, 2013
Last verified: April 2013
  Purpose

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.


Condition
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of the Glycemic Impact of Food in Patients With Type 2 Diabetes Taking Glargine and/or Exenatide

Resource links provided by NLM:


Further study details as provided by Park Nicollet Institute:

Primary Outcome Measures:
  • 4-hour glycemic response at 3 time points [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    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.


Enrollment: 46
Study Start Date: November 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Glargine Group
After baseline titration of metformin, this group will take glargine along with metformin.
Exenatide Group
After baseline titration of metformin, this group will take exenatide along with metformin.
Glargine and Exenatide Group
After baseline titration of metformin, this group will take glargine and exenatide along with metformin.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants in Clinical Trials Study NCT01089569

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01237314

Locations
United States, Minnesota
International Diabetes Center
Minneapolis, Minnesota, United States, 55416
Sponsors and Collaborators
Park Nicollet Institute
International Diabetes Center at Park Nicollet
Sanofi
Investigators
Principal Investigator: Maggie Powers, PhD International Diabetes Center at Park Nicollet
Principal Investigator: Alice Shapiro, PhD International Diabetes Center at Park Nicollet
  More Information

No publications provided

Responsible Party: Park Nicollet Institute
ClinicalTrials.gov Identifier: NCT01237314     History of Changes
Other Study ID Numbers: 04037-10-C
Study First Received: November 5, 2010
Last Updated: October 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Park Nicollet Institute:
type 2 diabetes
metformin
glargine
exenatide
glycemic impact of food
continuous glucose monitoring

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Exenatide
Glargine
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014