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Diabetes Mellitus, Type 2NCT03196895

Treating Type 2 Diabetes by Reducing Postprandial Glucose Elevations: A Paradigm Shift in Lifestyle Modification

A study testing Weight reduction training, PPG training and discrete BG feedback in people with Diabetes Mellitus, Type 2, run by University of Virginia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Conventional lifestyle modification in the management of type 2 diabetes focuses on weight loss, through caloric restriction and exercise, to reduce insulin resistance. This approach is limited because some people either do not need to lose weight, do not want to lose weight, cannot lose weight, or cannot maintain… Read more about this study

Who is it for?
Ages 21 to 80 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Weight reduction training, PPG training and discrete BG feedback
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
1 siteUnited States
Study dates
28 Jun 2017to 5 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with T2D in the last 10 years
  • HbA1c >7.5% (sub-optimal T2D control)
  • Between 21 and 80 years old
  • Not blind
  • Can read English
  • Routinely uses a smart phone

Who cannot join

  • Takes insulin (participants may start insulin during the study if clinically indicated)
  • Has taken medications that impede weight loss (e.g., prednisone) within the last 3 months
  • Currently pregnant or contemplating pregnancy within the next 15 months
  • Conditions that preclude increasing physical activity (e.g. severe neuropathy cardiovascular disease, chronic obstructive pulmonary disease/emphysema, osteoarthritis, stroke, or severe mental disease like manic depressive illness, severe depression, active substance abuse)
  • Undergoing treatment for cancer
  • History of lactic acidosis
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  • Marked renal impairment (eGFR < 45; stage 3b chronic kidney disease)
  • Takes psychotropic medications that raise blood glucose (e.g. atypical antipsychotics)
  • Cannot read English
  • Blindness
  • Cognitive impairment

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dept. of Psychiatry and Neurobehavioral Sciences, University of Virginia

    Charlottesville, Virginia, 22908

Other trials in United States

About this study

Conventional lifestyle modification in the management of type 2 diabetes focuses on weight loss, through caloric restriction and exercise, to reduce insulin resistance. This approach is limited because some people either do not need to lose weight, do not want to lose weight, cannot lose weight, or cannot maintain weight loss over a lifetime. This study proposes to evaluate the effectiveness of a lifestyle modification that focuses on reducing post-meal blood glucose (BG) elevations instead of weight loss. It works by teaching participants to: 1) choose low glycemic load foods that do not significantly increase their blood glucose, and 2) increase their routine physical activity after meals when it can offset post-meal blood glucose elevations. The study will also evaluate the role feedback about blood glucose fluctuations can play in improving the effectiveness of this program.

Read the detailed description

BACKGROUND: Type 2 diabetes (T2D) is a growing epidemic in the U.S. with devastating complications that result in major health and personal costs. To address this, the American Diabetes Association recommends a lifestyle program that focuses on weight loss through caloric restriction and exercise as an initial or an adjunct treatment to pharmacological interventions. However, its general applicability is limited because some individuals with T2D do not need to lose weight, do not want to lose weight, cannot lose weight, or cannot maintain weight loss over a lifetime. Recent research indicates that a major contributor to poor metabolic control is postprandial glucose (PPG) elevation. The researchers have developed a treatment option that focuses on reducing PPG without requiring weight loss. This lifestyle program is comprehensive, integrated, and efficient. Over 5 sessions, this program empowers individuals to use Glycemic load of food, Exercise, and Monitoring glucose (GEM) in a systematic manner. GEM's 1.03% HbA1c reduction compared favorably to both conventional weight loss (0.64% reduction with 42 sessions of Look AHEAD) and continual use of a first line medication (0.9% reduction with Metformin). When enhancing the quantity and quality of glucose feedback with Continuous Glucose Monitoring (CGM), GEM reduced HbA1c by 1.30%.

AIMS: This project will determine how GEM compares to conventional weight reduction at short- and long-term follow-up in a large, representative sample of adults with type 2 diabetes. At the same time, the researchers will test a conceptual model based on a review of the literature postulating that the effects of GEM are modulated by the quality and quantity of glucose feedback. This has important implications for long-term maintenance; since the model proposes a cascade in which increasing either the quantity or quality of glucose feedback improves immediate behavior change through positive and negative glucose consequences. These contingencies may lead to improved PPG and insulin sensitivity, and in turn, improved metabolic control. This cascade may produce ancillary benefits that could help maintain long-term success, e.g. greater empowerment and fewer depressive symptoms.

APPROACH: 200 participants with poorly controlled T2D will be randomized to 1 of 4 groups that manipulate both the focus on postprandial glucose and the quality and quantity of glucose feedback. Short- and long-term benefits will be assessed using medical, behavioral and psychological measures obtained at baseline, 3 months post-intervention and 12 months post-intervention.

IMPACT: If GEM is shown to be effective and enduring, it will provide an alternative to the conventional weight-loss focused lifestyle modification. GEM has the potential to improve metabolic control, increase self-reliance, and slow disease progression. Because GEM is manual-based, it will be easy to deploy and will give it the potential to impact a large proportion of the adults with T2D.

Being tested
Weight reduction training, PPG training, discrete BG feedback, continuous BG feedback
Keywords
Diabetes Mellitus, Type 2, Continuous Glucose Monitoring, Lifestyle Modification
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Weight reduction trainingBehavioural

    6 one-hour sessions of conventional weight reduction training

  • PPG trainingBehavioural

    Four 90-minute sessions of glycemic load and exercise training

  • discrete BG feedbackBehavioural

    Blood glucose feedback from structured self-monitoring of blood glucose

  • continuous BG feedbackBehavioural

    blood glucose feedback from continuous glucose monitoring

Study groups in NCT03196895
Study groupRoleWhat they receive
WRActive comparatorWeight reduction training
Receives: Behavioral: Weight reduction training
GEActive comparatorPPG training
Receives: Behavioral: PPG training
GEMExperimentalPPG training + discrete BG feedback
Receives: Behavioral: PPG training; Behavioral: discrete BG feedback
GEM+CGMExperimentalPPG training + continuous BG feedback
Receives: Behavioral: PPG training; Behavioral: continuous BG feedback

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in HbA1c

    change in HbA1c from baseline measure

    Measured: baseline, 3 months, and 12 months post-intervention

  2. change in medication

    change in medication type or dose from baseline measures

    Measured: baseline, 3 months, and 12 months post-intervention

Secondary outcomes (11)

  1. change in food choices (ASA24 survey)

    ASA24 survey across 3 separate days in each time frame

    Measured: baseline, 3 months, and 12 months post-intervention

  2. change in food choices (energy bar selection)

    At assessment visits, subjects will choose between energy bars that do or dont support the intervention principles.

    Measured: baseline, 3 months, and 12 months post-intervention

  3. change in physical activity (Fitbit activity monitor)

    daily activity will be recorded

    Measured: baseline, 3 months, and 12 months post-intervention

  4. change in psychological functioning (dietary habits questionnaire)

    The Food Questionnaire

    Measured: baseline, 3 months, and 12 months post-intervention

  5. change in psychological functioning (quality of life questionnaire)

    WHOQO-BREF questionnaire

    Measured: baseline, 3 months, and 12 months post-intervention

  6. change in psychological functioning (depression questionnaire)

    Patient Health Questionnaire (PHQ-9)

    Measured: baseline, 3 months, and 12 months post-intervention

  7. change in psychological functioning (numeracy questionnaire)

    Numeracy Scale - measures how good one is with numbers

    Measured: baseline, 3 months, and 12 months post-intervention

  8. change in psychological functioning (diabetes knowledge questionnaire)

    Diabetes Knowledge Scale

    Measured: baseline, 3 months, and 12 months post-intervention

  9. change in psychological functioning (empowerment questionnaire)

    Diabetes Empowerment Scale

    Measured: baseline, 3 months, and 12 months post-intervention

  10. change in psychological functioning (concerns about diabetes questionnaire)

    Diabetes Distress Scale (Emotional Distress \& Regimen Distress subscales)

    Measured: baseline, 3 months, and 12 months post-intervention

  11. change in psychological functioning (attitude towards glucose monitoring questionnaire)

    The Glucose Monitoring Satisfaction Survey (GMSS)

    Measured: baseline, 3 months, and 12 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2017
  2. Study start28 Jun 2017
  3. Primary completion5 Oct 2020
  4. Study completion5 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03196895
Sponsor's protocol ID
19370
Other IDs
1R01DK108957
Status last verified
Oct 2021
First submitted
28 Oct 2016
Last updated
5 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR; American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD). Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012 Jun;35(6):1364-79. doi: 10.2337/dc12-0413. Epub 2012 Apr 19. No abstract available.

    PubMed 22517736

  • Cox DJ, Gill Taylor A, Dunning ES, Winston MC, Luk Van IL, McCall A, Singh H, Yancy WS Jr. Impact of behavioral interventions in the management of adults with type 2 diabetes mellitus. Curr Diab Rep. 2013 Dec;13(6):860-8. doi: 10.1007/s11892-013-0423-7.

    PubMed 24072477

  • Hill JO, Galloway JM, Goley A, Marrero DG, Minners R, Montgomery B, Peterson GE, Ratner RE, Sanchez E, Aroda VR. Scientific statement: Socioecological determinants of prediabetes and type 2 diabetes. Diabetes Care. 2013 Aug;36(8):2430-9. doi: 10.2337/dc13-1161. Epub 2013 Jun 20. No abstract available.

    PubMed 23788649

  • Whiting DR, Guariguata L, Weil C, Shaw J. IDF diabetes atlas: global estimates of the prevalence of diabetes for 2011 and 2030. Diabetes Res Clin Pract. 2011 Dec;94(3):311-21. doi: 10.1016/j.diabres.2011.10.029. Epub 2011 Nov 12.

    PubMed 22079683

  • American Diabetes Association. Economic costs of diabetes in the U.S. in 2012. Diabetes Care. 2013 Apr;36(4):1033-46. doi: 10.2337/dc12-2625. Epub 2013 Mar 6.

    PubMed 23468086

  • Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). UK Prospective Diabetes Study (UKPDS) Group. JAMA. 1999 Jun 2;281(21):2005-12. doi: 10.1001/jama.281.21.2005.

    PubMed 10359389

  • Ceriello A, Davidson J, Hanefeld M, Leiter L, Monnier L, Owens D, Tajima N, Tuomilehto J; International Prandial Glucose Regulation Study Group. Postprandial hyperglycaemia and cardiovascular complications of diabetes: an update. Nutr Metab Cardiovasc Dis. 2006 Oct;16(7):453-6. doi: 10.1016/j.numecd.2006.05.006. Epub 2006 Aug 24.

    PubMed 16934443

  • Diabetes Prevention Program Research Group; Knowler WC, Fowler SE, Hamman RF, Christophi CA, Hoffman HJ, Brenneman AT, Brown-Friday JO, Goldberg R, Venditti E, Nathan DM. 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Lancet. 2009 Nov 14;374(9702):1677-86. doi: 10.1016/S0140-6736(09)61457-4. Epub 2009 Oct 29.

    PubMed 19878986

  • Look AHEAD Research Group; Wing RR. Long-term effects of a lifestyle intervention on weight and cardiovascular risk factors in individuals with type 2 diabetes mellitus: four-year results of the Look AHEAD trial. Arch Intern Med. 2010 Sep 27;170(17):1566-75. doi: 10.1001/archinternmed.2010.334.

    PubMed 20876408

  • Action to Control Cardiovascular Risk in Diabetes Study Group; Gerstein HC, Miller ME, Byington RP, Goff DC Jr, Bigger JT, Buse JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH Jr, Probstfield JL, Simons-Morton DG, Friedewald WT. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2545-59. doi: 10.1056/NEJMoa0802743. Epub 2008 Jun 6.

    PubMed 18539917

  • Look AHEAD Research Group; Pi-Sunyer X, Blackburn G, Brancati FL, Bray GA, Bright R, Clark JM, Curtis JM, Espeland MA, Foreyt JP, Graves K, Haffner SM, Harrison B, Hill JO, Horton ES, Jakicic J, Jeffery RW, Johnson KC, Kahn S, Kelley DE, Kitabchi AE, Knowler WC, Lewis CE, Maschak-Carey BJ, Montgomery B, Nathan DM, Patricio J, Peters A, Redmon JB, Reeves RS, Ryan DH, Safford M, Van Dorsten B, Wadden TA, Wagenknecht L, Wesche-Thobaben J, Wing RR, Yanovski SZ. Reduction in weight and cardiovascular disease risk factors in individuals with type 2 diabetes: one-year results of the look AHEAD trial. Diabetes Care. 2007 Jun;30(6):1374-83. doi: 10.2337/dc07-0048. Epub 2007 Mar 15.

    PubMed 17363746

  • DiPietro L, Gribok A, Stevens MS, Hamm LF, Rumpler W. Three 15-min bouts of moderate postmeal walking significantly improves 24-h glycemic control in older people at risk for impaired glucose tolerance. Diabetes Care. 2013 Oct;36(10):3262-8. doi: 10.2337/dc13-0084. Epub 2013 Jun 11.

    PubMed 23761134

  • Mayer-Davis EJ, D'Agostino R Jr, Karter AJ, Haffner SM, Rewers MJ, Saad M, Bergman RN. Intensity and amount of physical activity in relation to insulin sensitivity: the Insulin Resistance Atherosclerosis Study. JAMA. 1998 Mar 4;279(9):669-74. doi: 10.1001/jama.279.9.669.

    PubMed 9496984

  • Ingersoll KS, Banton T, Gorlin E, Vajda K, Singh H, Peterson N, Gonder-Frederick L, Cox DJ. Motivational Interviewing Support for a Behavioral Health Internet Intervention for Drivers with Type 1 Diabetes. Internet Interv. 2015 May 1;2(2):103-109. doi: 10.1016/j.invent.2015.02.001.

    PubMed 25774342

  • Hostmark AT, Ekeland GS, Beckstrom AC, Meen HD. Postprandial light physical activity blunts the blood glucose increase. Prev Med. 2006 May;42(5):369-71. doi: 10.1016/j.ypmed.2005.10.001. Epub 2006 Mar 20.

    PubMed 16549107

Questions about this trial

What is this clinical trial studying?

A study testing Weight reduction training, PPG training and discrete BG feedback in people with Diabetes Mellitus, Type 2, run by University of Virginia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in HbA1c (time frame: baseline, 3 months, and 12 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03196895, which also lists 62 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.

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