BMI-CDS for Obesity and Type 2 Diabetes

(BMI-CDS Trial)

Overseen By Heidi L Ekstrom, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HealthPartners Institute

Disqualifiers: Cancer, Dementia, Cirrhosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help doctors and patients make better decisions about obesity treatments, especially for those with type 2 diabetes. The study will test a new web-based tool called BMI-CDS, which provides personalized information on the benefits and risks of different weight loss options. Participants will be divided into two groups: one using the new tool and the other receiving standard care. The trial seeks adults with both type 2 diabetes and a BMI of 35 or higher who visit a family doctor or similar healthcare provider. As an unphased trial, participants can contribute to innovative research that may improve treatment decisions for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this decision-support intervention is safe for patients with obesity and type 2 diabetes?

Research shows that the BMI-CDS tool is a decision-support system, not a medication or surgery. Participants won't need to take any drugs or undergo an operation. Instead, it aids doctors and patients in making informed choices about weight loss options. As a decision-making tool, it poses no direct risks like side effects from medicine.

Because BMI-CDS involves no physical procedures, it is considered very safe for people with obesity and type 2 diabetes. Its purpose is to provide information, avoiding the risks associated with treatments like pills or surgeries.

For those considering joining a trial with BMI-CDS, the focus is on gaining better insights for managing weight, with no direct health risks from the tool itself. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about BMI-CDS for obesity and type 2 diabetes because it introduces shared decision support tools for weight loss management, which is a novel approach compared to standard treatments like lifestyle changes, medication, and surgery. These tools empower both clinicians and patients to make informed decisions together, potentially leading to more personalized and effective weight loss strategies. This collaborative method stands out as it actively involves patients in their treatment plans, which may enhance adherence and outcomes.

What evidence suggests that this decision-support intervention is effective for obesity and type 2 diabetes?

Research has shown that losing weight can help people with type 2 diabetes control their blood sugar more effectively and reduce the risk of heart issues. Studies have found that being overweight significantly increases the chance of developing type 2 diabetes. For men, the risk can rise from 7% to 70%, and for women, from 12% to 74%, as their body mass index (BMI) increases. In this trial, the BMI-CDS serves as an experimental tool to assist patients and doctors in selecting the best weight loss treatments by providing personalized estimates of the benefits and risks of different options. This tool can improve the management of obesity and diabetes. Participants in the control group will receive usual care without the BMI-CDS intervention. ^{4 6 7 8 9}

Who Is on the Research Team?

Patrick J O'Connor, MD, MPH, MA

Principal Investigator

HealthPartners Institute

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with obesity and type 2 diabetes, having a BMI of 35 or higher. They must have had an appointment at one of the study clinics during the accrual period. It's not open to pregnant or breastfeeding individuals, those with cancer (except non-melanoma skin cancer), dementia, cirrhosis, or those in long-term care.

Inclusion Criteria

I have been diagnosed with type 2 diabetes.

Have an index clinical encounter with a PCC (family practice or general internal medicine physician, nurse practitioner, or physician assistant) at a randomized study clinic during a 12-month accrual period

You have a body mass index (BMI) of 35 or higher.

Exclusion Criteria

History of a previous Modified Barium Swallow (MBS) procedure.

I have been diagnosed with cancer, dementia, or cirrhosis, excluding non-melanoma skin cancer.

Pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of a web-based point-of-care decision-support intervention in primary care clinics

18 months

Regular visits as per primary care schedule

Follow-up

Participants are monitored for changes in weight trajectory and other outcomes

18 months

What Are the Treatments Tested in This Trial?

Interventions

• BMI-CDS

Trial Overview The trial tests a web-based decision-support tool called BMI-CDS designed to help patients and doctors make informed choices about obesity treatments. The impact on weight management, patient satisfaction, and clinician satisfaction will be measured across different primary care clinics.

How Is the Trial Designed?

Group I: BMI-CDS Experimental Treatment 1 Intervention

Clinicians and their patients assigned to intervention clinics will receive shared decision support tools for weight loss management.

Group II: Usual Care Active Control 1 Intervention

Clinicians and their patients assigned to control clinics will engage in the usual standard of care.

Who Is Running the Clinical Trial?

HealthPartners Institute

Lead Sponsor

Trials

196

Recruited

3,721,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A one-year multimodal treatment program for severe obesity (BMI≥35.0 kg/m²) involving 190 participants showed significant improvements in body weight, waist circumference, eating disorder psychopathology, and quality of life from pre-treatment to post-treatment, with benefits maintained at a one-year follow-up.

Despite the promising results of the program, high rates of participant drop-out during the study limit the ability to draw strong conclusions, highlighting the need for further evaluations to strengthen the evidence base.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of the One-Year Multimodal Weight Loss Program DOC WEIGHT® 1.0 for Obesity Class II and III]. Rudolph, A., Hellbardt, M., Baldofski, S., et al.[2019]

Successful treatment of obesity should not only focus on weight loss but also consider other measures like body mass index, body fat percentage, and improvements in obesity-related health complications such as diabetes and hypertension.

As obesity is a chronic disease, maintaining weight loss is crucial, and treatment success should be defined with varying criteria for minimal, intermediate, and full success based on individual responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proposed standards for judging the success of the treatment of obesity. Atkinson, RL.[2019]

Obesity is a major health issue in Western countries, causing approximately 300,000 deaths annually in the U.S. and increasing the risk for various diseases, including liver disease and colon cancer.

Effective management of obesity includes lifestyle changes, and in some cases, medications or surgery, with a target of losing 10% of body weight within 6 months; currently, only two medications, sibutramine and orlistat, are approved for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical management of obesity. Kushner, RF.[2005]

New generation anti-obesity medications, such as orlistat, phentermine/topiramate, and liraglutide 3.0 mg, have varying safety profiles, with some presenting significant risks like fetal toxicity and gallstone disease, while others mainly cause transient tolerability issues.

Despite their effectiveness in weight loss, the prescription rates for these medications are low, partly due to safety concerns and the need for more long-term data to better understand their risk-benefit profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of new-generation anti-obesity medications: a narrative review. Patel, DK., Stanford, FC.[2023]

Surgical weight loss procedures significantly improve or resolve obesity-related medical issues for most patients, but the long-term effects on sustained weight loss and health improvements are still uncertain.

The American Society of Bariatric Surgery's new computer registry aims to standardize outcome analysis and improve patient selection for surgeries, which could enhance the effectiveness of weight loss interventions and ultimately improve health outcomes for morbidly obese patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of obesity surgery. Brolin, RE.[2005]

Roux-en-Y gastric bypass (RYGB) in patients with class I obesity (BMI 30.0-34.9 kg/m²) and type 2 diabetes resulted in significant weight loss (BMI decreased from 34.6 to 25.8 kg/m²) and improved glycemic control (HbA1c decreased from 8.2% to 6.1%) after one year, while the nonsurgical control group showed no significant changes.

Patients who underwent RYGB also reduced their use of antihypertensive and antihyperlipidemia medications, although this may have contributed to persistent high blood pressure and LDL cholesterol levels, indicating a need for careful medication management post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of bariatric surgery and nonsurgical therapy in adults with type 2 diabetes mellitus and body mass index Serrot, FJ., Dorman, RB., Miller, CJ., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5860843/

Clinical and Patient-Centered Outcomes in Obese Patients ... Weight loss in obese patients with type 2 diabetes often results in improved glycemic control and a reduction in cardiovascular risk factors such as ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10855901/

The Role of Obesity in Type 2 Diabetes Mellitus—An Overview A clinical trial involving LY2405319, a variant of FGF21, in obese individuals with type 2 DM showed improved body weights, decreased ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK592412/

Obesity and Type 2 Diabetes - StatPearls - NCBI Bookshelf Excess body weight significantly increases the lifetime risk of T2D, from 7% to 70% in men and from 12% to 74% in women, as BMI increases.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05198765

NCT05198765 | Weight Loss Clinical Decision Support The BMI-CDS is a sophisticated point of care shared decision support tool for patients with type 2 diabetes and high BMI. The intervention is built on ...

5. nature.com nature.com/articles/s41598-024-75179-6

Association between body mass index trajectories and type ... Medium and high-increasing BMI trajectory patterns have a significantly increased risk for future T2DM in both normoglycemic and prediabetic individuals.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7386102/

Association of Body Mass Index with the Risk of Incident Type ... In our study, the increased risk of incident diabetes began to be significant at around BMI 23 to 24 kg/m2 in both men and women. These values are close to the ...

7. cdc.gov cdc.gov/nchs/products/databriefs/db508.htm

Obesity and Severe Obesity Prevalence in Adults The prevalence of obesity among adults was 40.3% during August 2021–August 2023 (Figure 1, Table 1). The prevalence was 39.2% in men and 41.3% in women.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4887150/

Epidemiology of Obesity and Diabetes and Their ... However, when trends were examined by BMI categories, diabetes only increased among those who were obese (18.0% to 20.1%) suggesting that much of the increase ...

9. thelancet.com thelancet.com/journals/landia/article/PIIS2213-8587(25)00159-7/fulltext

Prevalence of clinical obesity versus BMI-defined ... Among the 97 060 individuals with clinical obesity and BMI data, 7117 (7·3%) had a normal BMI, 24 922 (25·7%) had overweight, 28693 (29·6%) had ...