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

October 4, 2021 updated by: Daniel Cox, PhD, University of Virginia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND: Type 2 diabetes (T2D) is a growing epidemic in the U.S. with devastating complications that result in major health and personal costs. To address this, the American Diabetes Association recommends a lifestyle program that focuses on weight loss through caloric restriction and exercise as an initial or an adjunct treatment to pharmacological interventions. However, its general applicability is limited because some individuals with T2D do not need to lose weight, do not want to lose weight, cannot lose weight, or cannot maintain weight loss over a lifetime. Recent research indicates that a major contributor to poor metabolic control is postprandial glucose (PPG) elevation. The researchers have developed a treatment option that focuses on reducing PPG without requiring weight loss. This lifestyle program is comprehensive, integrated, and efficient. Over 5 sessions, this program empowers individuals to use Glycemic load of food, Exercise, and Monitoring glucose (GEM) in a systematic manner. GEM's 1.03% HbA1c reduction compared favorably to both conventional weight loss (0.64% reduction with 42 sessions of Look AHEAD) and continual use of a first line medication (0.9% reduction with Metformin). When enhancing the quantity and quality of glucose feedback with Continuous Glucose Monitoring (CGM), GEM reduced HbA1c by 1.30%.

AIMS: This project will determine how GEM compares to conventional weight reduction at short- and long-term follow-up in a large, representative sample of adults with type 2 diabetes. At the same time, the researchers will test a conceptual model based on a review of the literature postulating that the effects of GEM are modulated by the quality and quantity of glucose feedback. This has important implications for long-term maintenance; since the model proposes a cascade in which increasing either the quantity or quality of glucose feedback improves immediate behavior change through positive and negative glucose consequences. These contingencies may lead to improved PPG and insulin sensitivity, and in turn, improved metabolic control. This cascade may produce ancillary benefits that could help maintain long-term success, e.g. greater empowerment and fewer depressive symptoms.

APPROACH: 200 participants with poorly controlled T2D will be randomized to 1 of 4 groups that manipulate both the focus on postprandial glucose and the quality and quantity of glucose feedback. Short- and long-term benefits will be assessed using medical, behavioral and psychological measures obtained at baseline, 3 months post-intervention and 12 months post-intervention.

IMPACT: If GEM is shown to be effective and enduring, it will provide an alternative to the conventional weight-loss focused lifestyle modification. GEM has the potential to improve metabolic control, increase self-reliance, and slow disease progression. Because GEM is manual-based, it will be easy to deploy and will give it the potential to impact a large proportion of the adults with T2D.

Study Type

Interventional

Enrollment (Actual)

192

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Dept. of Psychiatry and Neurobehavioral Sciences, University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with T2D in the last 10 years
  • HbA1c >7.5% (sub-optimal T2D control)
  • Between 21 and 80 years old
  • Not blind
  • Can read English
  • Routinely uses a smart phone

Exclusion Criteria:

  • Takes insulin (participants may start insulin during the study if clinically indicated)
  • Has taken medications that impede weight loss (e.g., prednisone) within the last 3 months
  • Currently pregnant or contemplating pregnancy within the next 15 months
  • Conditions that preclude increasing physical activity (e.g. severe neuropathy cardiovascular disease, chronic obstructive pulmonary disease/emphysema, osteoarthritis, stroke, or severe mental disease like manic depressive illness, severe depression, active substance abuse)
  • Undergoing treatment for cancer
  • History of lactic acidosis
  • Marked renal impairment (eGFR < 45; stage 3b chronic kidney disease)
  • Takes psychotropic medications that raise blood glucose (e.g. atypical antipsychotics)
  • Cannot read English
  • Blindness
  • Cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: WR
Weight reduction training
Behavioral: Weight reduction training
6 one-hour sessions of conventional weight reduction training
Active Comparator: GE
PPG training
Behavioral: PPG training
Four 90-minute sessions of glycemic load and exercise training
Experimental: GEM
PPG training + discrete BG feedback
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
Experimental: GEM+CGM
PPG training + continuous BG feedback
Behavioral: PPG training
Four 90-minute sessions of glycemic load and exercise training
Behavioral: continuous BG feedback
blood glucose feedback from continuous glucose monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in HbA1c
Time Frame: baseline, 3 months, and 12 months post-intervention
change in HbA1c from baseline measure
baseline, 3 months, and 12 months post-intervention
change in medication
Time Frame: baseline, 3 months, and 12 months post-intervention
change in medication type or dose from baseline measures
baseline, 3 months, and 12 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in food choices (ASA24 survey)
Time Frame: baseline, 3 months, and 12 months post-intervention
ASA24 survey across 3 separate days in each time frame
baseline, 3 months, and 12 months post-intervention
change in food choices (energy bar selection)
Time Frame: baseline, 3 months, and 12 months post-intervention
At assessment visits, subjects will choose between energy bars that do or dont support the intervention principles.
baseline, 3 months, and 12 months post-intervention
change in physical activity (Fitbit activity monitor)
Time Frame: baseline, 3 months, and 12 months post-intervention
daily activity will be recorded
baseline, 3 months, and 12 months post-intervention
change in psychological functioning (dietary habits questionnaire)
Time Frame: baseline, 3 months, and 12 months post-intervention
The Food Questionnaire
baseline, 3 months, and 12 months post-intervention
change in psychological functioning (quality of life questionnaire)
Time Frame: baseline, 3 months, and 12 months post-intervention
WHOQO-BREF questionnaire
baseline, 3 months, and 12 months post-intervention
change in psychological functioning (depression questionnaire)
Time Frame: baseline, 3 months, and 12 months post-intervention
Patient Health Questionnaire (PHQ-9)
baseline, 3 months, and 12 months post-intervention
change in psychological functioning (numeracy questionnaire)
Time Frame: baseline, 3 months, and 12 months post-intervention
Numeracy Scale - measures how good one is with numbers
baseline, 3 months, and 12 months post-intervention
change in psychological functioning (diabetes knowledge questionnaire)
Time Frame: baseline, 3 months, and 12 months post-intervention
Diabetes Knowledge Scale
baseline, 3 months, and 12 months post-intervention
change in psychological functioning (empowerment questionnaire)
Time Frame: baseline, 3 months, and 12 months post-intervention
Diabetes Empowerment Scale
baseline, 3 months, and 12 months post-intervention
change in psychological functioning (concerns about diabetes questionnaire)
Time Frame: baseline, 3 months, and 12 months post-intervention
Diabetes Distress Scale (Emotional Distress & Regimen Distress subscales)
baseline, 3 months, and 12 months post-intervention
change in psychological functioning (attitude towards glucose monitoring questionnaire)
Time Frame: baseline, 3 months, and 12 months post-intervention
The Glucose Monitoring Satisfaction Survey (GMSS)
baseline, 3 months, and 12 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

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

Investigators

  • Principal Investigator: Daniel J Cox, PhD, Dept. of Psychiatry and Neurobehavioral Sciences, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2017

Primary Completion (Actual)

October 5, 2020

Study Completion (Actual)

October 5, 2020

Study Registration Dates

First Submitted

October 28, 2016

First Submitted That Met QC Criteria

June 21, 2017

First Posted (Actual)

June 23, 2017

Study Record Updates

Last Update Posted (Actual)

October 5, 2021

Last Update Submitted That Met QC Criteria

October 4, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19370
  • 1R01DK108957 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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