Treating Type 2 Diabetes by Reducing Postprandial Glucose Elevations: A Paradigm Shift in Lifestyle Modification
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

Intervention name(s): Weight reduction training; PPG training; discrete BG feedback; continuous BG feedback
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): 6 one-hour sessions of conventional weight reduction training; Four 90-minute sessions of glycemic load and exercise training; Blood glucose feedback from structured self-monitoring of blood glucose; blood glucose feedback from continuous glucose monitoring
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2; Continuous Glucose Monitoring; Lifestyle Modification