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Randomized Pilot Trial of Bariatric Surgery Versus Intensive Medical Weight Management on Diabetes Remission in Type 2 Diabetic Patients Who Do NOT Meet NIH Criteria for Surgery and the Role of Soluble RAGE as a Novel Biomarker of Success

Parikh, Manish; Chung, Mimi; Sheth, Sheetal; McMacken, Michelle; Zahra, Tasneem; Saunders, John K; Ude-Welcome, Aku; Dunn, Van; Ogedegbe, Gbenga; Schmidt, Ann Marie; Pachter, H Leon
OBJECTIVE: To compare bariatric surgery versus intensive medical weight management (MWM) in patients with type 2 diabetes mellitus (T2DM) who do not meet current National Institutes of Health criteria for bariatric surgery and to assess whether the soluble form of receptor for advanced glycation end products (sRAGE) is a biomarker to identify patients most likely to benefit from surgery. BACKGROUND: There are few studies comparing surgery to MWM for patients with T2DM and BMI less than 35. METHODS: Fifty-seven patients with T2DM and BMI 30 to 35, who otherwise met the criteria for bariatric surgery were randomized to MWM versus surgery (bypass, sleeve or band, based on patient preference). The primary outcomes assessed at 6 months were change in homeostatic model of insulin resistance (HOMA-IR) and diabetes remission. Secondary outcomes included changes in HbA1c, weight, and sRAGE. RESULTS: The surgery group had improved HOMA-IR (-4.6 vs +1.6; P = 0.0004) and higher diabetes remission (65% vs 0%, P < 0.0001) than the MWM group at 6 months. Compared to MWM, the surgery group had lower HbA1c (6.2 vs 7.8, P = 0.002), lower fasting glucose (99.5 vs 157; P = 0.0068), and fewer T2DM medication requirements (20% vs 88%; P < 0.0001) at 6 months. The surgery group lost more weight (7. vs 1.0 BMI decrease, P < 0.0001). Higher baseline sRAGE was associated with better weight loss outcomes (r = -0.641; P = 0.046). There were no mortalities. CONCLUSIONS: Surgery was very effective short-term in patients with T2DM and BMI 30 to 35. Baseline sRAGE may predict patients most likely to benefit from surgery. These findings need to be confirmed with larger studies.ClinicalTrials.gov ID: NCT01423877.
PMCID:4691842
PMID: 25203878
ISSN: 0003-4932
CID: 1186772

Tuberculous prostate abscesses in an immunocompetent patient: A dramatic presentation of disseminated tuberculosis

Johnson, Matthew G; Caplan-Shaw, Caralee E; McMacken, Michelle
Genitourinary tuberculosis (TB) is infrequently reported in the United States, but is a common form of extrapulmonary TB that often goes unnoticed due to its insidious and sometimes asymptomatic presentation. Prostate involvement and the development of tuberculous prostatic abscesses have been reported in the literature largely in association with human immunodeficiency virus (HIV) infection and acquired immunodeficiency syndrome (AIDS). We report a case of disseminated TB involving tuberculous prostatic abscesses in a patient without HIV/AIDS, presenting with sepsis and urinary symptoms. This patient had simultaneous prostatic, peritoneal, pulmonary, and likely renal TB, serving as a reminder to clinicians that multi-organ presentations of TB do occur in patients without overt immunosuppressive conditions. This case also highlights the importance of considering the diagnosis of genitourinary TB in patients with risk factors for TB presenting with vague, long-standing urinary symptoms.
PMCID:4067608
PMID: 24967218
ISSN: 2248-2997
CID: 1051312

A structured weight management program for obese patients in an urban safety-net hospital center

Chapter by: McMacken, Michelle; Moore, Sarah; Randlett, Diana; Parikh, Lisa
in: Obesity interventions in underserved communities: Evidence and directions by Brennan, Virginia M; Kumanyika, Shiriki K; Zambrana, Ruth Enid [Eds]
Baltimore, MD : Johns Hopkins University Press; US, 2014
pp. 353-361
ISBN: 1-4214-1545-3
CID: 1522462

Role of Bariatric Surgery as Treatment for Type 2 Diabetes in Patients Who Do Not Meet Current NIH Criteria: A Systematic Review and Meta-Analysis

Parikh, Manish; Issa, Reda; Vieira, Dorice; McMacken, Michelle; Saunders, John K; Ude-Welcome, Aku; Schubart, Ulrich; Ogedegbe, Gbenga; Pachter, H Leon
PMID: 23890843
ISSN: 1072-7515
CID: 512922

PREDICTORS OF WEIGHT LOSS IN AN URBAN, SAFETY-NET HOSPITAL WEIGHT MANAGEMENT PROGRAM. [Meeting Abstract]

Weerahandi, Himali; Patterson, Elenore; Ahn, Albert; Deza, Camila; Parikh, Lisa; Pierre, Gaelle C; Gillespie, Colleen; McMacken, Michelle
ISI:000209142900421
ISSN: 1525-1497
CID: 2782342

FACTORS INFLUENCING ADHERENCE TO AN URBAN PUBLIC HOSPITAL WEIGHT MANAGEMENT PROGRAM [Meeting Abstract]

Weerahandi, Himali; Parikh, Lisa; Pierre, Gaelle C; Diskin, Brian; Patterson, Elenore; Ahn, Albert; Deza, Camila; Gillespie, Colleen; McMacken, Michelle
ISI:000209142900222
ISSN: 1525-1497
CID: 2782332

How to deliver high-quality obesity counseling in primary care using the 5As framework

Schlair, S; Moore, S; McMacken, M; Jay, M
* Objective: To review the content of the 5As of obesity counseling for primary care physicians as well as strategies to efficiently address the 5As during a typical 20-minute visit. * Methods: Review of the literature. * Results: Obese patients are evaluated in the primary care setting for multiple weight-related comorbidities and often seek help from their primary care providers to lose weight. Several studies have suggested that physicians and other providers do not adequately counsel obese patients about their weight because of barriers such as poor reimbursement, lack of obesity-related counseling skills, and lack of time. The 5As (Assess, Advise, Agree, Assist, Arrange) is an evidence-based, behavior-change counseling framework endorsed by the Centers for Medicare and Medicaid Services and the United States Preventive Services Task Force. * Conclusion: With the recent announcement that Medicare will now cover intensive behavioral counseling for obese patients, more providers may be interested in gaining the necessary skills to provide high-quality weight management counseling
EMBASE:2012284423
ISSN: 1079-6533
CID: 167824

Does a preoperative medically supervised weight loss program improve bariatric surgery outcomes? A pilot randomized study

Parikh, Manish; Dasari, Meena; McMacken, Michelle; Ren, Christine; Fielding, George; Ogedegbe, Gbenga
BACKGROUND: Many insurance payors mandate that bariatric surgery candidates undergo a medically supervised weight management (MSWM) program as a prerequisite for surgery. However, there is little evidence to support this requirement. We evaluated in a randomized controlled trial the hypothesis that participation in a MSWM program does not predict outcomes after laparoscopic adjustable gastric banding (LAGB) in a publicly insured population. METHODS: This pilot randomized trial was conducted in a large academic urban public hospital. Patients who met NIH consensus criteria for bariatric surgery and whose insurance did not require a mandatory 6-month MSWM program were randomized to a MSWM program with monthly visits over 6 months (individual or group) or usual care for 6 months and then followed for bariatric surgery outcomes postoperatively. Demographics, weight, and patient behavior scores, including patient adherence, eating behavior, patient activation, and physical activity, were collected at baseline and at 6 months (immediately preoperatively and postoperatively). RESULTS: A total of 55 patients were enrolled in the study with complete follow-up on 23 patients. Participants randomized to a MSWM program attended an average of 2 sessions preoperatively. The majority of participants were female and non-Caucasian, mean age was 46 years, average income was less than $20,000/year, and most had Medicaid as their primary insurer, consistent with the demographics of the hospital's bariatric surgery program. Data analysis included both intention-to-treat and completers' analyses. No significant differences in weight loss and most patient behaviors were found between the two groups postoperatively, suggesting that participation in a MSWM program did not improve weight loss outcomes for LAGB. Participation in a MSWM program did appear to have a positive effect on physical activity postoperatively. CONCLUSION: MSWM does not appear to confer additional benefit as compared to the standard preoperative bariatric surgery protocol in terms of weight loss and most behavioral outcomes after LAGB in our patient population.
PMID: 22011946
ISSN: 0930-2794
CID: 158642

Does a preoperative medically supervised weight loss program improve bariatric surgery outcomes: A pilot randomized study [Meeting Abstract]

Dasari M.; Ayo D.; McMacken M.; Ogedegbe O.; Parikh M.
Introduction: Participation in a medically-supervised weight management (MSWM) program before bariatric surgery is mandated by several insurance payers. However, this requirement is not evidencebased and serves as a barrier to medically necessary treatment. We conducted a pilot randomized trial funded by SAGES to determine the effect of an insurance-mandated MSWM prior to surgery. Our hypotheses are: (1) There is no difference in BMI between patients who have participated in a medically-supervised weight management program and those who don't. (2) MSWM does not change self-reported adherence, physical activity, eating behavior, and health beliefs. Methods & Procedures: 55 patients were scheduled for laparoscopic adjustable gastric banding (LAGB) and consented to enroll in an ongoing prospective pilot study in a large public hospital. of these, 12 patients cancelled surgery and 10 patients have been enrolled for less than 6 months. Thus, 33 patients were included in the analysis, with 17 randomized to MSWM (defined as monthly visits over 6 months directed by a physician or nutritionist) and 16 randomized to usual care. Measures of weight, height, adherence, activity level, health beliefs, and eating behavior were obtained at enrollment (ie, baseline) and 6 months after enrollment (ie, MSWM program completion and 2 weeks prior to surgery). For categorical and continuous data, Fisher's Exact Test and t-test were used to compare groups at the 2 time points before surgery. Results: Mean age was 45.5 (SD = 12.5) years. Majority were female (97%) and non-Caucasian (85%) with an income of less than $20,000 (64%). No significant differences were found between MSWM and usual care for age, gender, ethnicity, education, and income, indicating that the 2 groups were evenly matched for demographic variables. Mean BMI for the MSWM group was 46.3 kg/m2 at baseline and 46.0 kg/m2 at 6 months. Mean BMI for usual care was 44.7 kg/m2 and 44.6 kg/m2 (see Table 1). After 6 months of eitherMSWMor wait and at pre-surgery, no significant differences in BMIor patient behaviors were found between the 2 groups. Preliminary analysis of available 3-month post-operative data (n = 13) showed similar mean BMI when comparing MSWM (41.3 kg/m2) and usual care (41.2 kg/m 2). Conclusion: Our preliminary results indicate that MSWM does not affect BMI changes or patient behaviors prior to or after LAGB surgery
EMBASE:70470141
ISSN: 0930-2794
CID: 135628

A CASE OF BLEEDING ESOPHAGEAL VARICES IN A PATIENT WITH GRANULOMATOUS LIVER CIRRHOSIS [Meeting Abstract]

Wu, S; Altman, D; Deza, C; McMacken, M
ISI:000277282300598
ISSN: 0884-8734
CID: 111923