Clincosm LogoSign in Get a demo

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

Sponsor
University of Virginia (Other)
Overall Status
Completed
CT.gov ID
NCT03196895
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
192
Enrollment
1
Location
4
Arms
39.3
Actual Duration (Months)
4.9
Patients Per Site Per Month

Study Details

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.
Condition or Disease Intervention/Treatment Phase
  • Behavioral: Weight reduction training
  • Behavioral: PPG training
  • Behavioral: discrete BG feedback
  • Behavioral: continuous BG feedback
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
192 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treating Type 2 Diabetes by Reducing Postprandial Glucose Elevations: A Paradigm Shift in Lifestyle Modification
Actual Study Start Date :
Jun 28, 2017
Actual Primary Completion Date :
Oct 5, 2020
Actual Study Completion Date :
Oct 5, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. change in HbA1c [baseline, 3 months, and 12 months post-intervention]

    change in HbA1c from baseline measure

  2. change in medication [baseline, 3 months, and 12 months post-intervention]

    change in medication type or dose from baseline measures

Secondary Outcome Measures

  1. change in food choices (ASA24 survey) [baseline, 3 months, and 12 months post-intervention]

    ASA24 survey across 3 separate days in each time frame

  2. change in food choices (energy bar selection) [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.

  3. change in physical activity (Fitbit activity monitor) [baseline, 3 months, and 12 months post-intervention]

    daily activity will be recorded

  4. change in psychological functioning (dietary habits questionnaire) [baseline, 3 months, and 12 months post-intervention]

    The Food Questionnaire

  5. change in psychological functioning (quality of life questionnaire) [baseline, 3 months, and 12 months post-intervention]

    WHOQO-BREF questionnaire

  6. change in psychological functioning (depression questionnaire) [baseline, 3 months, and 12 months post-intervention]

    Patient Health Questionnaire (PHQ-9)

  7. change in psychological functioning (numeracy questionnaire) [baseline, 3 months, and 12 months post-intervention]

    Numeracy Scale - measures how good one is with numbers

  8. change in psychological functioning (diabetes knowledge questionnaire) [baseline, 3 months, and 12 months post-intervention]

    Diabetes Knowledge Scale

  9. change in psychological functioning (empowerment questionnaire) [baseline, 3 months, and 12 months post-intervention]

    Diabetes Empowerment Scale

  10. change in psychological functioning (concerns about diabetes questionnaire) [baseline, 3 months, and 12 months post-intervention]

    Diabetes Distress Scale (Emotional Distress & Regimen Distress subscales)

  11. change in psychological functioning (attitude towards glucose monitoring questionnaire) [baseline, 3 months, and 12 months post-intervention]

    The Glucose Monitoring Satisfaction Survey (GMSS)

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dept. of Psychiatry and Neurobehavioral Sciences, University of Virginia Charlottesville Virginia United States 22908

Sponsors and Collaborators

  • University of Virginia
  • 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Daniel Cox, PhD, Professor, Departments of Psychiatry, Internal Medicine and Ophthalmology, University of Virginia
ClinicalTrials.gov Identifier:
NCT03196895
Other Study ID Numbers:
  • 19370
  • 1R01DK108957
First Posted:
Jun 23, 2017
Last Update Posted:
Oct 5, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Daniel Cox, PhD, Professor, Departments of Psychiatry, Internal Medicine and Ophthalmology, University of Virginia
Diabetes Mellitus, Type 2
Continuous Glucose Monitoring
Lifestyle Modification
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Oct 5, 2021