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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03196895
• Other study ID #: 19370
• Secondary ID: 1R01DK108957
• Status: Completed
• Phase: N/A
• Start date: June 28, 2017
• Est. completion date: October 5, 2020

Study information

• Verified date: October 2021
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: October 5, 2020
• Est. primary completion date: October 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Weight reduction training
6 one-hour sessions of conventional weight reduction training
• PPG training
Four 90-minute sessions of glycemic load and exercise training
• discrete BG feedback
Blood glucose feedback from structured self-monitoring of blood glucose
• continuous BG feedback
blood glucose feedback from continuous glucose monitoring

Locations

Country	Name	City	State
United States	Dept. of Psychiatry and Neurobehavioral Sciences, University of Virginia	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

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* Note: There are 60 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in HbA1c	change in HbA1c from baseline measure	baseline, 3 months, and 12 months post-intervention
Primary	change in medication	change in medication type or dose from baseline measures	baseline, 3 months, and 12 months post-intervention
Secondary	change in food choices (ASA24 survey)	ASA24 survey across 3 separate days in each time frame	baseline, 3 months, and 12 months post-intervention
Secondary	change in food choices (energy bar selection)	At assessment visits, subjects will choose between energy bars that do or dont support the intervention principles.	baseline, 3 months, and 12 months post-intervention
Secondary	change in physical activity (Fitbit activity monitor)	daily activity will be recorded	baseline, 3 months, and 12 months post-intervention
Secondary	change in psychological functioning (dietary habits questionnaire)	The Food Questionnaire	baseline, 3 months, and 12 months post-intervention
Secondary	change in psychological functioning (quality of life questionnaire)	WHOQO-BREF questionnaire	baseline, 3 months, and 12 months post-intervention
Secondary	change in psychological functioning (depression questionnaire)	Patient Health Questionnaire (PHQ-9)	baseline, 3 months, and 12 months post-intervention
Secondary	change in psychological functioning (numeracy questionnaire)	Numeracy Scale - measures how good one is with numbers	baseline, 3 months, and 12 months post-intervention
Secondary	change in psychological functioning (diabetes knowledge questionnaire)	Diabetes Knowledge Scale	baseline, 3 months, and 12 months post-intervention
Secondary	change in psychological functioning (empowerment questionnaire)	Diabetes Empowerment Scale	baseline, 3 months, and 12 months post-intervention
Secondary	change in psychological functioning (concerns about diabetes questionnaire)	Diabetes Distress Scale (Emotional Distress & Regimen Distress subscales)	baseline, 3 months, and 12 months post-intervention
Secondary	change in psychological functioning (attitude towards glucose monitoring questionnaire)	The Glucose Monitoring Satisfaction Survey (GMSS)	baseline, 3 months, and 12 months post-intervention

External Links

•   American Diabetes Association (2012). Living with diabetes: Complications. Retrieved on 5/17/15
•   Centers for Disease Control and Prevention national diabetes statistics report, 2014. Retrieved 2/18/16