Funded by the following endowments:

• Dr. Edward C. Faulkner Endowment
• Dolan Medical Endowment
• Haynes Family Endowment
• Michael A. and Agnes Marchigiano

Criteria for selection:

Proposals will be reviewed and ranked by the GME Group for promoting resident and fellow scholarly activity.

• Increases Creighton GME programs scholarly activity through presentations and publications
• Likelihood that the project will be successfully completed within one year
• Likelihood that the project will advance the department’s collaboration and mentorship that enhances the environment of scholarly activity
• High impact to patient care or clinical education
• Justification why this project merits additional funds on top of already established funds for scholarly activity
• All recipients must provide a brief, progress report at the end of the academic year to the GMEC

The proposal must follow the format below: 

STUDY TITLE (1 Line)

Effect of bariatric surgery on pharmacokinetics of medications for obesity-related comorbidities 

REQUESTING FACULTY/DIVISION (1 Line) 

Dr. Kalyana Nandipati - General Surgery 

STUDY TIME FRAME (1 Line) 

The study time frame will be one year 

STUDY PURPOSE (1 Paragraph) 

Purpose: To obtain drug levels of medications commonly used for obesity ­related comorbidities after sleeve gastrectomy or gastric bypass 

Hypothesis: Patients undergoing bariatric surgery will have subtherapeutic serum levels of medications for obesity-related comorbidities 

Clearly define the purpose of the study, objectives to be accomplished, and specific questions/hypotheses to be answered/tested:

• State concisely and realistically what the study described in this proposal is intended to accomplish
• The purpose, objectives, questions/hypotheses should be clearly defined
• A statement of purpose, describing how the project will help meet departmental, GME, or university goals, and how scholarly work will ultimately improve as a result of the project
• A project design, describing what will be done
• A timeline for completion of the project. (for example - include whether an abstract has been accepted and when the meeting is held)
• The expected product(s) of the project

BACKGROUND AND SIGNIFICANCE (1-2 Paragraphs) 

The worldwide prevalence of obesity has doubled since the 1980s. Obesity is related to many comorbidities and increased mortality. Bariatric surgery is the most effective method to treat morbid obesity (B I > 40 
kg/m2). Roux en Y gastric bypass and sleeve gastrectomy are the two most commonly performed weight loss surgery options across the World. In these surgeries, the stomach size is either reduced (in both surgeries) into a or bypassed to increase the transit time. With the changes in anatomy, volume, and pH of a Roux en y gastric bypass or sleeve gastrectomy, the absorption of certain obesity-related medications may become sub- or super­therapeutic. It is well known that Roux en y gastric bypass results in problems regarding nutrient and vitamin absorption, however few studies have examined the effect of bariatric surgery on serum levels of orally administered medications. 

Many medications have a narrow therapeutic window. These medications include antiseizure medications (valproic acid, phenytoin, carbamazepine, levetiracetam, topiramate), antihypertensives (lisinopril, hydrochlorothlazide, metoprolol and amlodipine), antiplatelets (clopidogrel), or cholesterol lowering medications (statins). Many patients are also on novel oral anticoagulants (Coumadin, apixaban and rivaroxaban) as well. Patients on these medications may need dosing adjustments to maintain therapeutic levels. To date, there have been no published data on trials examining the effect of bariatric surgeries on these medications. With our study, we will examine whether these weight loss surgeries have a significant effect on therapeutic serum levels post-surgery. These studies will identify the need for medication adjustment post-surgery and examine potential side effects if serum medication levels are outside of therapeutic range after these increasingly more common bariatric procedures. 

Provide a summary of the literature, background, and rationale for the study. Why is it important that the specific questions/hypotheses be answered/tested? 

• Briefly sketch the background to the proposal listing key references, critically evaluate existing knowledge, and specifically identify the questions that the study is intended to answer
• State concisely the importance of the study described in this proposal by relating the specific purpose and objectives to the overall need in the community/environment of interest

DESIGN AND METHODS (1-2 Paragraphs)

Objectives: Prospective study to determine the effects of bariatric surgery on therapeutic levels of different medications. Patients that are currently prescribed antihypertensives, antiplatelets, antiseizure, or anticoagulants will be stratified according to the weight loss surgery. After IRB approval of the study, patients will be obtained from the bariatric clinic and patients undergoing weight loss surgery (Dr. Kalyana Nandipati and Dr. Michael Hovey). They will be included before surgery and followed as per standard protocol. The serum drug levels will be obtained pre-surgery, 3 and &-months after surgery. These serum levels will then be examined and compared to standard ranges in patients without bariatric surgery. A total of 25 patients will be enrolled in to the study group. The serum drug levels will be compared to normal therapeutic ranges for each drug. A comparison between therapeutic levels in sleeve gastrectomy compared to roux en y gastric bypass will also be performed. Comparison will also be performed between levels pre-surgery, 3 and 6 months’ after surgery. Statistical significance will be determined as a p-value < 0.05.

Briefly describe the study design, population to be studied (e.g., who are the subjects, inclusion/exclusion criteria), data source (e.g., administrative claims data, survey data, registry/national/regional database, prospective study) intervention (if any), and specific measurements/instruments to be used (include any reliability and validity information) in the data collection process. 

• Outline the research design and procedures that will be used to accomplish the specific study objectives
• Describe how the data will be collected, analyzed, and interpreted
• Describe any special challenges or methodological approaches required for the study

ANALYSIS/PLAN (1 Paragraph)

In order to examine the effects of bariatric surgery on therapeutic levels of medications, quantitative measurements will be obtained by serum collection. Valproic acid, phenytoin, levetiracetam, carbamazepine, lisinopril, amlodipine, and hydrochlorothlazide levels will be obtained by specific analysis of serum concentration. Clopidogrel will be measured by using VerifyNow P2Y12 measurement device. Levels of apixaban and rlvaroxaban will be measured using factor Xa levels. Direct levels will be averaged and compared between which group the patients have been stratified. Baseline measurements will be obtained and compared to levels 3- and 6-months post operation. Levels will be obtained and compared to recommended therapeutic levels at these time points. 

What quantitative and/or qualitative techniques will be used to answer/test each question/hypothesis? 

• This section may be addressed and/or expanded upon after discussion with the Division

RESOURCES REQUIRED & TIME LINE (1 Paragraph)

State specific resource requirements related to time lines, computer programming, and analytical support. 

• Clearly delineate the roles and responsibilities between the requestor of the study and the Division
• List specific deadline(s) and any equipment or personnel that may impact the study
• Submit a budget as to how the money will be utilized and when it will be spent
• Budget information should be included indicating:
  • The amount requested, the person(s) for whom the funds are requested, and the justification for the funds requested
  • Brief descriptions and costs

Criteria for Selection

• Proposals will be reviewed and ranked by the GME Group for promoting resident and fellow scholarly activity.
• Able to lead to promoting Creighton GME programs reputation through presentations/publication.
• Likelihood that the project will be successfully completed.
• Likelihood that the project will advance the department’s environment of scholarly activity.
• High impact to patient care or clinical education (including translation projects supposed to improve patient care)
• Justification why this project

Procedures for Application

A title page clearly indicating:

• A project title
• A short (fewer than 100 words) project abstract
• Names and contact information for all project participants/investigators. Identify the principal investigator

Proposals should not exceed one page (proposal body and dollars requested), single-spaced, in 12-point font. Each proposal must include:

The proposal body indicating: 

• A statement of purpose, describing how the project will help meet departmental, GME, or university goals, and how scholarly work will ultimately improve as a result of the project
• A project design, describing what will be done
• A time line for completion of the project. (for example - include whether an abstract has been accepted and when the meeting is held)
• The expected product(s) of the project

Budget information indicating:

• The amount requested, the person(s) for whom the funds are requested, and the justification for the funds requested
• Brief descriptions and costs
• Expectations for Recipients
• All recipients must provide a brief, progress report at the end of the academic year to the GMEC. 

Reviewers Guidelines

• Evaluate each application on its own merit
• Will not compare other grant proposals under review
• Avoid personal bias
• Maintain confidentiality
• Avoid a conflict of interest such as actively applying for the same funding mechanism

Reviewer Check List

Grant Score