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

NCT ID: NCT03196895

Last Updated: 2021-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-28
• Study Completion Date: 2020-10-05

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

WR

Weight reduction training

Group Type: ACTIVE_COMPARATOR

Weight reduction training

Intervention Type: BEHAVIORAL

6 one-hour sessions of conventional weight reduction training

GE

PPG training

Group Type: ACTIVE_COMPARATOR

PPG training

Intervention Type: BEHAVIORAL

Four 90-minute sessions of glycemic load and exercise training

GEM

PPG training + discrete BG feedback

Group Type: EXPERIMENTAL

PPG training

Intervention Type: BEHAVIORAL

Four 90-minute sessions of glycemic load and exercise training

discrete BG feedback

Intervention Type: BEHAVIORAL

Blood glucose feedback from structured self-monitoring of blood glucose

GEM+CGM

PPG training + continuous BG feedback

Group Type: EXPERIMENTAL

PPG training

Intervention Type: BEHAVIORAL

Four 90-minute sessions of glycemic load and exercise training

continuous BG feedback

Intervention Type: BEHAVIORAL

blood glucose feedback from continuous glucose monitoring

Interventions

Weight reduction training

6 one-hour sessions of conventional weight reduction training

Intervention Type: BEHAVIORAL

PPG training

Four 90-minute sessions of glycemic load and exercise training

Intervention Type: BEHAVIORAL

discrete BG feedback

Blood glucose feedback from structured self-monitoring of blood glucose

Intervention Type: BEHAVIORAL

continuous BG feedback

blood glucose feedback from continuous glucose monitoring

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Daniel Cox, PhD

Professor, Departments of Psychiatry, Internal Medicine and Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel J Cox, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Psychiatry and Neurobehavioral Sciences, University of Virginia

Locations

Dept. of Psychiatry and Neurobehavioral Sciences, University of Virginia

Charlottesville, Virginia, United States

Countries

United States

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Other Identifiers

1R01DK108957

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19370

Identifier Type: -

Identifier Source: org_study_id