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

NCT01237314 | Completed

• 1 other identifier: 04037-10-C
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes; metformin; glargine; exenatide; glycemic impact of food; continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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 Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants in Clinical Trials Study NCT01089569

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• HealthPartners Institute: lead
• International Diabetes Center at Park Nicollet: collaborator
• Sanofi: collaborator

Study Sites (1)

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Maggie Powers, PhD

  International Diabetes Center at Park Nicollet

  PRINCIPAL INVESTIGATOR

• Alice Shapiro, PhD

  International Diabetes Center at Park Nicollet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2010
• First Posted: November 9, 2010
• Study Start: November 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: December 2, 2015

Record last verified: 2013-04

Locations

US (1)