Identifying Clinical Predictors of Weight Loss in Older Adults with Diabetes: Insights from SURPASS Clinical Trials

Lead Investigator: Javier Calvo, Universidad de Costa Rica
Title of Proposal Research: Identifying Clinical Predictors of Weight Loss in Older Adults with Diabetes: Insights from SURPASS Clinical Trials
Vivli Data Request: 10360
Funding Source: None
Potential Conflicts of Interest: Dr. Javier Calvo reported: Potential Conflicts of Interest:
Endocare, my secondary employer, is a private practice endocrinology office. As an endocrinologist at Endocare, I do not have any exclusivity agreements with public, private, or pharmaceutical institutions. I can choose therapeutic options for my patients based on clinical evidence and patient needs. Additionally, I give academic lectures in non-profit settings and when hired by different companies.
I address potential conflicts of interest that could be perceived to influence the planning, conduct, interpretation, or outcomes of the proposed research.
Approach to Managing Potential Conflicts of Interest:
– Full Disclosure: I will ensure full disclosure of my employment with Endocare in all publications, presentations, and communications related to this research. This transparency will allow readers and reviewers to consider any potential biases.
– Independence in Research: In this study, my position at Endocare will not influence data evaluation. The research will be conducted independently, and the analysis will be based solely on the data collected from the SURPASS trials and the scientific merit of the findings.
– No Financial Ties to Tirzepatide: I do not have any financial interest or conflict of interest related to the use or prescription of Tirzepatide. My role at Endocare does not affect my ability to analyze and interpret the data from the SURPASS trials objectively.
– Ethical Standards: The research will adhere to the highest ethical standards, ensuring that the study design, data analysis, and interpretation of results are conducted with integrity and impartiality.
– Peer Review and Oversight: The research findings will be submitted to peer-reviewed journals, where they will undergo rigorous evaluation by independent experts. This process will further ensure that the research is unbiased and credible.
By addressing these potential conflicts of interest transparently and maintaining rigorous standards of ethical conduct, I aim to uphold the integrity of the research and contribute to answering frequent clinical scenarios in the field of endocrinology.
Dr. Gabriel Torrealba-Acosta reported: As an Assistant Professor in the Department of Neurology at Duke University, I, Gabriel Torrealba-Acosta, do not participate in any administrative decisions related to the companies represented in the SURPASS trials. My role at Duke University is strictly academic and clinical, focusing on research and patient care without any involvement in the administrative aspects of these companies. Additionally, I am not bound by any exclusivity agreements with public, private, or pharmaceutical institutions and can choose therapeutic options for my patients based on clinical evidence and patient needs.
I address potential conflicts of interest that could be perceived to influence the planning, conduct, interpretation, or outcomes of the proposed research.
Approach to Managing Potential Conflicts of Interest:
Full Disclosure: I will ensure full disclosure of my employment with Duke University in all publications, presentations, and communications related to this research. This transparency will allow readers and reviewers to consider any potential biases.
Independence in Research: My position at Duke University will not influence data evaluation in this study. The research will be conducted independently, and the analysis will be based solely on the data collected from the SURPASS trials and the scientific merit of the findings.
No Financial Ties to Represented Companies: I do not have any financial interest or conflict of interest related to the use or prescription of any products from the companies represented in the SURPASS trials. My role at Duke University does not affect my ability to objectively analyze and interpret the data from the SURPASS trials.
Ethical Standards: The research will adhere to the highest ethical standards, ensuring that the study design, data analysis, and interpretation of results are conducted with integrity and impartiality.
Peer Review and Oversight: The research findings will be submitted to peer-reviewed journals, which will undergo rigorous evaluation by independent experts. This process will further ensure that the research is unbiased and credible.
Dr. Francis Ruiz Salazar: Endocare, my secondary employer, is a private practice endocrinology office. As an endocrinologist at Endocare, I do not have any exclusivity agreements with public, private, or pharmaceutical institutions. I can choose therapeutic options for my patients based on clinical evidence and patient needs. Additionally, I give academic lectures in non-profit settings and when hired by different companies.
I address potential conflicts of interest that could be perceived to influence the planning, conduct, interpretation, or outcomes of the proposed research.
Approach to Managing Potential Conflicts of Interest:
– Full Disclosure: I will ensure full disclosure of my employment with Endocare in all publications, presentations, and communications related to this research. This transparency will allow readers and reviewers to consider any potential biases.
– Independence in Research: In this study, my position at Endocare will not influence data evaluation. The research will be conducted independently, and the analysis will be based solely on the data collected from the SURPASS trials and the scientific merit of the findings.
– No Financial Ties to Tirzepatide: I do not have any financial interest or conflict of interest related to the use or prescription of Tirzepatide. My role at Endocare does not affect my ability to analyze and interpret the data from the SURPASS trials objectively.
– Ethical Standards: The research will adhere to the highest ethical standards, ensuring that the study design, data analysis, and interpretation of results are conducted with integrity and impartiality.
– Peer Review and Oversight: The research findings will be submitted to peer-reviewed journals, where they will undergo rigorous evaluation by independent experts. This process will further ensure that the research is unbiased and credible.
By transparently addressing these potential conflicts of interest and maintaining rigorous standards of ethical conduct, I aim to uphold the integrity of the research and contribute to answering frequent clinical scenarios in endocrinology.
Dr. Maria Victoria Mora Gomez: Endocare, my secondary employer, is a private practice endocrinology office. As an endocrinologist at Endocare, I do not have any exclusivity agreements with public, private, or pharmaceutical institutions. I can choose therapeutic options for my patients based on clinical evidence and patient needs. Additionally, I give academic lectures in non-profit settings and when hired by different companies.
I address potential conflicts of interest that could be perceived to influence the planning, conduct, interpretation, or outcomes of the proposed research.
Approach to Managing Potential Conflicts of Interest:
– Full Disclosure: I will ensure full disclosure of my employment with Endocare in all publications, presentations, and communications related to this research. This transparency will allow readers and reviewers to consider any potential biases.
– Independence in Research: In this study, my position at Endocare will not influence data evaluation. The research will be conducted independently, and the analysis will be based solely on the data collected from the SURPASS trials and the scientific merit of the findings.
– No Financial Ties to Tirzepatide: I do not have any financial interest or conflict of interest related to the use or prescription of Tirzepatide. My role at Endocare does not affect my ability to analyze and interpret the data from the SURPASS trials objectively.
– Ethical Standards: The research will adhere to the highest ethical standards, ensuring that the study design, data analysis, and interpretation of results are conducted with integrity and impartiality.
– Peer Review and Oversight: The research findings will be submitted to peer-reviewed journals, where they will undergo rigorous evaluation by independent experts. This process will further ensure that the research is unbiased and credible.
By transparently addressing these potential conflicts of interest and maintaining rigorous standards of ethical conduct, I aim to uphold the integrity of the research and contribute to answering frequent clinical scenarios in endocrinology.

Summary of the Proposed Research:

Overall Brief Description:

This research aims to understand why some older adults with diabetes lose more weight than others. By analyzing data from the SURPASS clinical trials, we seek to identify specific health characteristics, treatments, and lifestyle factors that contribute to weight loss in this population. Our goal is to use these insights to help healthcare providers develop personalized strategies that can better support weight management and overall health in adults older than 65 years living with type 2 diabetes.

Type 2 diabetes:
Type 2 diabetes is a common condition that affects how the body processes blood sugar. It occurs when the body becomes resistant to insulin, a hormone that regulates blood sugar, or when the pancreas is unable to produce enough insulin. This leads to elevated levels of glucose in the blood, which can cause serious health problems over time. Globally, over 400 million people are living with type 2 diabetes, making it a significant public health concern.In the United States of America, approximately one in ten people has diabetes.

Research Design and Methods:

The research will be conducted through a retrospective analysis of existing data from the SURPASS clinical trials which included 6,720 participants. These trials included a comprehensive collection of demographic, health status, and treatment-related data for older adults with diabetes.
The SURPASS trials are a group of randomized clinical trials aimed at understanding the efficacy of different treatments in various clinical scenarios of diabetes. For this study, we will analyze the data with a focus on weight loss reductions, using continuous variables such as weight, Body Mass Index (BMI), lean mass (body weight excluding fat), fat mass (weight of fat in the body), and visceral adipose tissue (fat stored deep in the body, for example around organs).

Tirzepatide is an antidiabetic medication used for the treatment of diabetes and for weight loss. It is a GLP-1-GIP (Glucagon-Like Peptide-1/ Glucose-Dependent Insulinotropic Polypeptide) dual receptor agonist, this means it mimics GLP-1 and GIP hormones that are naturally secreted by the intestine after a meal, which prompts insulin secretion. The insulin then allows sugar (glucose) in the blood to be absorbed by the body. Tirzepatide also reduces appetite by slowing down the time it takes the stomach to empty and by interacting with the brain to signal fullness.

We will use models to assess the real impact of tirzepatide. Statistical methods will be employed to evaluate the relationships between the weight-related variables and clinical predictors (such as age, gender, baseline health status, and treatment regimens) and weight loss outcomes.

Contribution to Medical Science or Patient Care:

This research will add valuable knowledge to the field of endocrinology by identifying clinical predictors of weight loss in older adults with diabetes. Improved weight management can reduce complications associated with diabetes, thereby enhancing the quality of life for these patients. Additionally, it is clinically relevant to understand which factors drive more extensive weight loss, as an outcome it is not always wanted in this population. Previous studies have explored weight loss in diabetic populations, but there is limited research specifically focused on older adults. By leveraging the extensive data from the SURPASS trials, we aim to fill this gap in the literature.

Requested Studies:

Efficacy and Safety of LY3298176 Once Weekly Versus Insulin Glargine in Patients With Type 2 Diabetes and Increased Cardiovascular Risk (SURPASS-4)
Data Contributor: Lilly
Study ID: NCT03730662
Sponsor ID: 17072

A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of Tirzepatide Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
Data Contributor: Lilly
Study ID: NCT03987919
Sponsor ID: 17001

A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Three Tirzepatide Doses Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone
Data Contributor: Lilly
Study ID: NCT03954834
Sponsor ID: 17000

A Randomized, Phase 3, Open-label Trial Comparing the Effect of Tirzepatide Once Weekly Versus Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes on Metformin With or Without a Sulfonylurea
Data Contributor: Lilly
Study ID: NCT04093752
Sponsor ID: 17210

A Randomized, Phase 3, Open-Label Trial Comparing the Effect of LY3298176 Versus Titrated Insulin Degludec on Glycemic Control in Patients With Type 2 Diabetes
Data Contributor: Lilly
Study ID: NCT03882970
Sponsor ID: 16997