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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight reduction training
PPG training
discrete BG feedback
continuous BG feedback
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2, Continuous Glucose Monitoring, Lifestyle Modification

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept. of Psychiatry and Neurobehavioral Sciences, University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Arm Label

WR

GE

GEM

GEM+CGM

Arm Description

Weight reduction training

PPG training

PPG training + discrete BG feedback

PPG training + continuous BG feedback

Outcomes

Primary Outcome Measures

change in HbA1c
change in HbA1c from baseline measure
change in medication
change in medication type or dose from baseline measures

Secondary Outcome Measures

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

Full Information

First Posted
October 28, 2016
Last Updated
October 4, 2021
Sponsor
University of Virginia
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03196895
Brief Title
Treating Type 2 Diabetes by Reducing Postprandial Glucose Elevations: A Paradigm Shift in Lifestyle Modification
Official Title
Treating Type 2 Diabetes by Reducing Postprandial Glucose Elevations: A Paradigm Shift in Lifestyle Modification
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 28, 2017 (Actual)
Primary Completion Date
October 5, 2020 (Actual)
Study Completion Date
October 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes Mellitus, Type 2, Continuous Glucose Monitoring, Lifestyle Modification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WR
Arm Type
Active Comparator
Arm Description
Weight reduction training
Arm Title
GE
Arm Type
Active Comparator
Arm Description
PPG training
Arm Title
GEM
Arm Type
Experimental
Arm Description
PPG training + discrete BG feedback
Arm Title
GEM+CGM
Arm Type
Experimental
Arm Description
PPG training + continuous BG feedback
Intervention Type
Behavioral
Intervention Name(s)
Weight reduction training
Intervention Description
6 one-hour sessions of conventional weight reduction training
Intervention Type
Behavioral
Intervention Name(s)
PPG training
Intervention Description
Four 90-minute sessions of glycemic load and exercise training
Intervention Type
Behavioral
Intervention Name(s)
discrete BG feedback
Intervention Description
Blood glucose feedback from structured self-monitoring of blood glucose
Intervention Type
Behavioral
Intervention Name(s)
continuous BG feedback
Intervention Description
blood glucose feedback from continuous glucose monitoring
Primary Outcome Measure Information:
Title
change in HbA1c
Description
change in HbA1c from baseline measure
Time Frame
baseline, 3 months, and 12 months post-intervention
Title
change in medication
Description
change in medication type or dose from baseline measures
Time Frame
baseline, 3 months, and 12 months post-intervention
Secondary Outcome Measure Information:
Title
change in food choices (ASA24 survey)
Description
ASA24 survey across 3 separate days in each time frame
Time Frame
baseline, 3 months, and 12 months post-intervention
Title
change in food choices (energy bar selection)
Description
At assessment visits, subjects will choose between energy bars that do or dont support the intervention principles.
Time Frame
baseline, 3 months, and 12 months post-intervention
Title
change in physical activity (Fitbit activity monitor)
Description
daily activity will be recorded
Time Frame
baseline, 3 months, and 12 months post-intervention
Title
change in psychological functioning (dietary habits questionnaire)
Description
The Food Questionnaire
Time Frame
baseline, 3 months, and 12 months post-intervention
Title
change in psychological functioning (quality of life questionnaire)
Description
WHOQO-BREF questionnaire
Time Frame
baseline, 3 months, and 12 months post-intervention
Title
change in psychological functioning (depression questionnaire)
Description
Patient Health Questionnaire (PHQ-9)
Time Frame
baseline, 3 months, and 12 months post-intervention
Title
change in psychological functioning (numeracy questionnaire)
Description
Numeracy Scale - measures how good one is with numbers
Time Frame
baseline, 3 months, and 12 months post-intervention
Title
change in psychological functioning (diabetes knowledge questionnaire)
Description
Diabetes Knowledge Scale
Time Frame
baseline, 3 months, and 12 months post-intervention
Title
change in psychological functioning (empowerment questionnaire)
Description
Diabetes Empowerment Scale
Time Frame
baseline, 3 months, and 12 months post-intervention
Title
change in psychological functioning (concerns about diabetes questionnaire)
Description
Diabetes Distress Scale (Emotional Distress & Regimen Distress subscales)
Time Frame
baseline, 3 months, and 12 months post-intervention
Title
change in psychological functioning (attitude towards glucose monitoring questionnaire)
Description
The Glucose Monitoring Satisfaction Survey (GMSS)
Time Frame
baseline, 3 months, and 12 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J Cox, PhD
Organizational Affiliation
Dept. of Psychiatry and Neurobehavioral Sciences, University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Psychiatry and Neurobehavioral Sciences, University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Links:
URL
http://www.diabetes.org/living-with-diabetes/complications/
Description
American Diabetes Association (2012). Living with diabetes: Complications. Retrieved on 5/17/15

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

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