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

University of Virginia

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: GEM

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02432391

16293

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 24 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

47 participants in 2 patient groups

Routine Care

No Intervention group

Description:

Participants continue their routine medical care for type 2 diabetes

GEM

Experimental group

Description:

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

Treatment:

Behavioral: GEM