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Completed

NCT Number: NCT02432391

Lifestyle Modification for Type 2 Diabetes Involving Reduction of After-meal Blood Glucose Elevations

The purpose of this study is to determine if a lifestyle modification program (GEM) that focuses on reducing after-meal blood glucose elevations can improve blood glucose control in people with type 2 diabetes. Half of the participants will continue their routine medical care, and half will receive five sessions of GEM in addition to their routine care. The two groups will be assessed using diabetes-relevant medical, behavioral and psychological measures.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

24 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22908, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with type 2 diabetes within the past 5 years
  • Age >24 and <80 years
  • HbA1c >7.0%
  • Approval of primary care physician to participate

Exclusion criteria

  • Currently using, or used within the last 3 months, medications that directly lower BG (e.g., insulin, sulfonylureas, glinides, or DPP-4 inhibitors).
  • Currently using, or used within the last 3 months, thiazides at doses above HCTZ 25 mg or equivalent, or loop diuretics above furosemide 20mg or equivalent.
  • Currently pregnant or contemplating pregnancy in the coming year
  • Currently using, or used within the last 3 months, medications that impede weight loss (e.g., prednisone)
  • Having conditions that preclude increasing physical activity, e.g. severe neuropathy, active cardiovascular disease, emphysema, osteoarthritis, stroke.
  • Undergoing cancer treatment
  • History of lactic acidosis
  • Diagnosed with renal impairment

Treatment and study plan

GEM

Behavioral

GEM is an integrated lifestyle modification program that focuses on reducing postprandial blood glucose through replacing high with low glycemic load foods and increasing routine physical activity guided by systematic blood glucose monitoring.

Primary outcomes

  1. Change from baseline glycosylated hemoglobin at 6 months

    Time frame: 0 and 6 months

    HbA1c

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • LifeScan

Registry information

Official study title

Self-Monitoring of Blood Glucose (SMBG) as an Educational Tool and a Negative Feedback Loop to Reinforce Blood Glucose Lowering and Discourage Blood Glucose Elevating Self-Management Behaviors in Adults With T2DM

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 4, 2015
Registry last updated
May 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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