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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Routine Care

Participants continue their routine medical care for type 2 diabetes

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

GEM

Intervention Type 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.

Interventions

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GEM

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

24 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No