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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: GEM

• Registration Number: NCT02432391
• Lead Sponsor: University of Virginia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-04
• Study First Submitted: 2015-04-24
• Study First Submitted QC: 2015-04-28
• Last Update Submitted: 2015-04-28
• Study First Posted: 2015-05-04
• Last Update Posted: 2015-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GEM	GEM	Participants receive the GEM (Glycemic load, Exercise, and Monitoring blood glucose) lifestyle modification program and continue their routine medical care for type 2 diabetes.

Primary Outcome Measures

Name	Time	Method
Change from baseline glycosylated hemoglobin at 6 months	0 and 6 months	HbA1c

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States