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Trial record 5 of 860 for:    Recruiting, Not yet recruiting, Available Studies | "Diabetes Mellitus, Type 2"

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

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ClinicalTrials.gov Identifier: NCT03196895
Recruitment Status : Recruiting
First Posted : June 23, 2017
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Daniel Cox, PhD, University of Virginia

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
Diabetes Mellitus, Type 2 Behavioral: Weight reduction training Behavioral: PPG training Behavioral: discrete BG feedback Behavioral: continuous BG feedback

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  (Clinical Trial)
Estimated Enrollment : 200 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 : June 28, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. change in HbA1c [ Time Frame: baseline, 3 months, and 12 months post-intervention ]
    change in HbA1c from baseline measure

  2. change in medication [ Time Frame: 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) [ Time Frame: 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) [ 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.

  3. change in physical activity (Fitbit activity monitor) [ Time Frame: baseline, 3 months, and 12 months post-intervention ]
    daily activity will be recorded

  4. change in psychological functioning (dietary habits questionnaire) [ Time Frame: baseline, 3 months, and 12 months post-intervention ]
    The Food Questionnaire

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

  6. change in psychological functioning (depression questionnaire) [ Time Frame: baseline, 3 months, and 12 months post-intervention ]
    Patient Health Questionnaire (PHQ-9)

  7. 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

  8. change in psychological functioning (diabetes knowledge questionnaire) [ Time Frame: baseline, 3 months, and 12 months post-intervention ]
    Diabetes Knowledge Scale

  9. change in psychological functioning (empowerment questionnaire) [ Time Frame: baseline, 3 months, and 12 months post-intervention ]
    Diabetes Empowerment Scale

  10. 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)

  11. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03196895


Contacts
Contact: Tom A Banton, OD, PhD 434-924-8656 tab2v@hscmail.mcc.virginia.edu
Contact: Daniel J Cox, PhD 434-924-8021 djc4f@virginia.edu

Locations
United States, Virginia
Dept. of Psychiatry and Neurobehavioral Sciences, University of Virginia Recruiting
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

Additional Information:
Publications:

Responsible Party: Daniel Cox, PhD, Professor, Departments of Psychiatry, Internal Medicine and Ophthalmology, University of Virginia
ClinicalTrials.gov Identifier: NCT03196895     History of Changes
Other Study ID Numbers: 19370
1R01DK108957 ( U.S. NIH Grant/Contract )
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
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, University of Virginia:
Diabetes Mellitus, Type 2
Continuous Glucose Monitoring
Lifestyle Modification

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases