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Treating Type 2 Diabetes by Reducing Postprandial Glucose Elevations: A Paradigm Shift in Lifestyle Modification

NCT03196895 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2021-10-05

No results posted yet for this study

Summary

Conventional lifestyle modification in the management of type 2 diabetes focuses on weight loss, through caloric restriction and exercise, to reduce insulin resistance. This approach is limited because some people either do not need to lose weight, do not want to lose weight, cannot lose weight, or cannot maintain weight loss over a lifetime. This study proposes to evaluate the effectiveness of a lifestyle modification that focuses on reducing post-meal blood glucose (BG) elevations instead of weight loss. It works by teaching participants to: 1) choose low glycemic load foods that do not significantly increase their blood glucose, and 2) increase their routine physical activity after meals when it can offset post-meal blood glucose elevations. The study will also evaluate the role feedback about blood glucose fluctuations can play in improving the effectiveness of this program.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

BEHAVIORAL

Weight reduction training

6 one-hour sessions of conventional weight reduction training

BEHAVIORAL

PPG training

Four 90-minute sessions of glycemic load and exercise training

BEHAVIORAL

discrete BG feedback

Blood glucose feedback from structured self-monitoring of blood glucose

BEHAVIORAL

continuous BG feedback

blood glucose feedback from continuous glucose monitoring

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Virginia

    lead OTHER

Principal Investigators

  • Daniel J Cox, PhD · Dept. of Psychiatry and Neurobehavioral Sciences, University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-28
Primary Completion
2020-10-05
Completion
2020-10-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03196895 on ClinicalTrials.gov