Clinical trial NCT03196895: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Continuous Glucose Monitoring
Lifestyle Modification
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-06-23
Enrollment: 192
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: change in HbA1c
timeFrame: baseline, 3 months, and 12 months post-intervention
measure: change in medication
timeFrame: baseline, 3 months, and 12 months post-intervention
Secondary outcomes:
measure: change in food choices (ASA24 survey)
timeFrame: baseline, 3 months, and 12 months post-intervention
measure: change in food choices (energy bar selection)
timeFrame: baseline, 3 months, and 12 months post-intervention
measure: change in physical activity (Fitbit activity monitor)
timeFrame: baseline, 3 months, and 12 months post-intervention
measure: change in psychological functioning (dietary habits questionnaire)
timeFrame: baseline, 3 months, and 12 months post-intervention
measure: change in psychological functioning (quality of life questionnaire)
timeFrame: baseline, 3 months, and 12 months post-intervention
measure: change in psychological functioning (depression questionnaire)
timeFrame: baseline, 3 months, and 12 months post-intervention
measure: change in psychological functioning (numeracy questionnaire)
timeFrame: baseline, 3 months, and 12 months post-intervention
measure: change in psychological functioning (diabetes knowledge questionnaire)
timeFrame: baseline, 3 months, and 12 months post-intervention
measure: change in psychological functioning (empowerment questionnaire)
timeFrame: baseline, 3 months, and 12 months post-intervention
measure: change in psychological functioning (concerns about diabetes questionnaire)
timeFrame: baseline, 3 months, and 12 months post-intervention
measure: change in psychological functioning (attitude towards glucose monitoring questionnaire)
timeFrame: baseline, 3 months, and 12 months post-intervention
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: Dept. of Psychiatry and Neurobehavioral Sciences, University of Virginia
state: Virginia
Study officials:
affiliation: Dept. of Psychiatry and Neurobehavioral Sciences, University of Virginia
name: Daniel J Cox, PhD
role: PRINCIPAL_INVESTIGATOR
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