Treating Type 2 Diabetes by Reducing Postprandial Glucose Elevations: A Paradigm Shift in Lifestyle Modification
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 21 - 80 |
| Updated: | 10/28/2017 |
| Start Date: | June 28, 2017 |
| End Date: | August 2021 |
| Contact: | Tom A Banton, OD, PhD |
| Email: | tab2v@hscmail.mcc.virginia.edu |
| Phone: | 434-924-8656 |
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.
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.
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.
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.
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
We found this trial at
1
site
1215 Lee Street
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
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