Treating Type 2 Diabetes by Reducing Postprandial Glucose Elevations: A Paradigm Shift in Lifestyle Modification
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Behavioral: PPG trainingBehavioral: Weight reduction trainingBehavioral: continuous BG feedbackBehavioral: discrete BG feedback
- Registration Number
- NCT03196895
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 192
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GEM+CGM continuous BG feedback PPG training + continuous BG feedback GEM PPG training PPG training + discrete BG feedback WR Weight reduction training Weight reduction training GEM discrete BG feedback PPG training + discrete BG feedback GE PPG training PPG training GEM+CGM PPG training PPG training + continuous BG feedback
- Primary Outcome Measures
Name Time Method change in HbA1c baseline, 3 months, and 12 months post-intervention change in HbA1c from baseline measure
change in medication baseline, 3 months, and 12 months post-intervention change in medication type or dose from baseline measures
- Secondary Outcome Measures
Name Time Method change in psychological functioning (depression questionnaire) baseline, 3 months, and 12 months post-intervention Patient Health Questionnaire (PHQ-9)
change in physical activity (Fitbit activity monitor) baseline, 3 months, and 12 months post-intervention daily activity will be recorded
change in psychological functioning (quality of life questionnaire) baseline, 3 months, and 12 months post-intervention WHOQO-BREF questionnaire
change in psychological functioning (concerns about diabetes questionnaire) baseline, 3 months, and 12 months post-intervention Diabetes Distress Scale (Emotional Distress \& Regimen Distress subscales)
change in psychological functioning (dietary habits questionnaire) baseline, 3 months, and 12 months post-intervention The Food Questionnaire
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.
change in psychological functioning (numeracy questionnaire) baseline, 3 months, and 12 months post-intervention Numeracy Scale - measures how good one is with numbers
change in food choices (ASA24 survey) baseline, 3 months, and 12 months post-intervention ASA24 survey across 3 separate days in each time frame
change in psychological functioning (diabetes knowledge questionnaire) baseline, 3 months, and 12 months post-intervention Diabetes Knowledge Scale
change in psychological functioning (empowerment questionnaire) baseline, 3 months, and 12 months post-intervention Diabetes Empowerment Scale
change in psychological functioning (attitude towards glucose monitoring questionnaire) baseline, 3 months, and 12 months post-intervention The Glucose Monitoring Satisfaction Survey (GMSS)
Trial Locations
- Locations (1)
Dept. of Psychiatry and Neurobehavioral Sciences, University of Virginia
šŗšøCharlottesville, Virginia, United States