Impact of Plasma Soluble Prorenin Receptor in Obese and Type 2 Diabetic Patients

NCT03643783 | Completed

• 1 other identifier: 2018-374
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity increases the risk for type 2 diabetes mellitus, high blood pressure, and mortality. Obesity is a major health problem in the United States, especially in the Deep South regions. Obesity increases the risk for T2DM, the occurrence of hypertension, and mortality; but the efficacy of long-term weight loss medications has been disappointing. There are three options available for patients who want to lose weight: lifestyle modification, pills, or weight loss by bariatric surgery. When we compare the three options available, bariatric surgery is the most effective method to lose weight at present. Bariatric surgery allows patients lose the most weight, be able to sustain the weight reduction over time and, more importantly, diabetes mellitus and other cardiovascular risk factors significantly improve. Understanding the link among obesitydiabetes-hypertension is crucial in order to develop new therapeutic targets to decrease CVD morbidity and mortality. There is less prevalence of coronary artery disease (CAD) in premenopausal women than in men, but, once initiated, the morbidity and mortality due to CAD in women is worse than in men, thus highlighting this sex difference in CVD. Indeed, women with diabetes exhibit a higher risk of myocardial infarction and stroke mortality than men, compared to people without diabetes. In obese subjects, there is inappropriate activation of the systemic and adipose renin-angiotensin system. The prorenin receptor is a molecule expressed in various tissues including fat tissue and part of it, the soluble prorenin receptor, can be secreted into the blood. The prorenin receptor is part of a very important system that regulates blood pressure and fat in our body, the renin-angiotensin system. In this prospective observational human pilot study, we will determine whether the adipose tissue is the major supplier of soluble prorenin receptor levels in the plasma of obese patients and the relationship between blood soluble prorenin receptor and diabetes mellitus, obesity, high blood pressure and other important cardiovascular risk factors. Outcomes from this study will allow a better understanding of the complex factors that link obesity, diabetes mellitus, and other cardiovascular risk factors and designing better therapeutic alternatives to improve patient's health, particularly in obese diabetic women.

Conditions

Obesity; Type2 Diabetes; Bariatric Surgery Candidate

Keywords

Bariatric Surgery; Prorenin; Hypertension; Obesity

Outcome Measures

Primary Outcomes (2)

• Change in plasma levels of sPRR

  Determine whether changes in plasma levels of sPRR decrease in obese patients after bariatric surgery.

  1 month and 6 months postop

• Change in T2DM parameters and sPRR after surgery

  Define whether changes in plasma levels of sPRR correlate with improvement of T2DM parameters in obese patients subsequent to weight loss after bariatric surgery.

  1 month and 6 months postop

Study Arms (2)

Bariatric Obese Patients

Obese patients, including men and women, White (Caucasians), Africa American, and Hispanic or Latino racial categories, and ages 18-70 years, who are enrolled and planning to undertake bariatric surgery in the Outpatient Bariatric Surgery Clinic at Tulane University, HSC (Christopher G. Ducoin, MD, MPH; Chair of Bariatric Surgery Clinic and Surgeon, and Shauna Levy, MD, Bariatric Surgeon Specialist).

Lean Control Patients

Plasma samples from lean control patients that have already been collected and are available as part of the Tulane Obesity-Endocannabinoids Study (Tina Thethi, M.D, Collaborator).

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese men and women of all races between the ages of 18-70 who are scheduled to undergo bariatric surgery.

You may qualify if:

• Men and women 18-70 years of age
• Scheduled to undergo bariatric surgery
• Obese (defined as BMI \>=30)

You may not qualify if:

• History of hemorrhagic stroke or myocardium infarction in the previous 6 months.
• Women who are currently pregnant
• Diagnosed with a malignant disease
• Uncontrolled diabetes mellitus (defined as HbA1c\>10.0%)

Sponsors & Collaborators

• Tulane University: lead
• Tulane University Health Sciences Center: collaborator
• UAB-CCTS Network Mulitdisciplinary Pilot Program: collaborator

Study Sites (1)

Tulane Medical Center

New Orleans, Louisiana, 70112, United States

Location

Related Publications (19)

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MeSH Terms

Conditions

Obesity; Hypertension

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Minolfa Prieto, MD PhD

  Tulane University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 23, 2018
• Study Start: September 11, 2018
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: March 1, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)