NCT02432391

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 4, 2015

Completed
Last Updated

May 4, 2015

Status Verified

April 1, 2015

Enrollment Period

1.7 years

First QC Date

April 24, 2015

Last Update Submit

April 28, 2015

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change from baseline glycosylated hemoglobin at 6 months

    HbA1c

    0 and 6 months

Study Arms (2)

Routine Care

NO INTERVENTION

Participants continue their routine medical care for type 2 diabetes

GEM

EXPERIMENTAL

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

Behavioral: GEM

Interventions

GEMBEHAVIORAL

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.

GEM

Eligibility Criteria

Age24 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

  • Cox DJ, Fang K, McCall AL, Conaway MR, Banton TA, Moncrief MA, Diamond AM, Taylor AG. Behavioral Strategies to Lower Postprandial Glucose in Those with Type 2 Diabetes May Also Lower Risk of Coronary Heart Disease. Diabetes Ther. 2019 Feb;10(1):277-281. doi: 10.1007/s13300-018-0554-6. Epub 2018 Dec 18.

    PMID: 30565055DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Daniel Cox, PhD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Psychiatry and NB Sciences

Study Record Dates

First Submitted

April 24, 2015

First Posted

May 4, 2015

Study Start

May 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

May 4, 2015

Record last verified: 2015-04

Locations

US(1)