Effect of bariatric surgery versus intensive medical management on diabetic ophthalmic outcomes.
Ontology highlight
ABSTRACT:
SUBMITTER: Singh RP
PROVIDER: S-EPMC4338505 | biostudies-literature | 2015 Mar
REPOSITORIES: biostudies-literature
Publications
Effect of bariatric surgery versus intensive medical management on diabetic ophthalmic outcomes.
Singh Rishi P RP Gans Richard R Kashyap Sangeeta R SR Bedi Rumneek R Wolski Kathy K Brethauer Stacy A SA Nissen Steven E SE Bhatt Deepak L DL Schauer Philip P
Diabetes care 20150301 3
Similar Datasets
Project description:BackgroundLong-term results from randomized, controlled trials that compare medical therapy with surgical therapy in patients with type 2 diabetes are limited.MethodsWe assessed outcomes 5 years after 150 patients who had type 2 diabetes and a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 27 to 43 were randomly assigned to receive intensive medical therapy alone or intensive medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy. The primary outcome was a glycated hemoglobin level of 6.0% or less with or without the use of diabetes medications.ResultsOf the 150 patients who underwent randomization, 1 patient died during the 5-year follow-up period; 134 of the remaining 149 patients (90%) completed 5 years of follow-up. At baseline, the mean (±SD) age of the 134 patients was 49±8 years, 66% were women, the mean glycated hemoglobin level was 9.2±1.5%, and the mean BMI was 37±3.5. At 5 years, the criterion for the primary end point was met by 2 of 38 patients (5%) who received medical therapy alone, as compared with 14 of 49 patients (29%) who underwent gastric bypass (unadjusted P=0.01, adjusted P=0.03, P=0.08 in the intention-to-treat analysis) and 11 of 47 patients (23%) who underwent sleeve gastrectomy (unadjusted P=0.03, adjusted P=0.07, P=0.17 in the intention-to-treat analysis). Patients who underwent surgical procedures had a greater mean percentage reduction from baseline in glycated hemoglobin level than did patients who received medical therapy alone (2.1% vs. 0.3%, P=0.003). At 5 years, changes from baseline observed in the gastric-bypass and sleeve-gastrectomy groups were superior to the changes seen in the medical-therapy group with respect to body weight (-23%, -19%, and -5% in the gastric-bypass, sleeve-gastrectomy, and medical-therapy groups, respectively), triglyceride level (-40%, -29%, and -8%), high-density lipoprotein cholesterol level (32%, 30%, and 7%), use of insulin (-35%, -34%, and -13%), and quality-of-life measures (general health score increases of 17, 16, and 0.3; scores on the RAND 36-Item Health Survey ranged from 0 to 100, with higher scores indicating better health) (P<0.05 for all comparisons). No major late surgical complications were reported except for one reoperation.ConclusionsFive-year outcome data showed that, among patients with type 2 diabetes and a BMI of 27 to 43, bariatric surgery plus intensive medical therapy was more effective than intensive medical therapy alone in decreasing, or in some cases resolving, hyperglycemia. (Funded by Ethicon Endo-Surgery and others; STAMPEDE ClinicalTrials.gov number, NCT00432809 .).
| S-EPMC5451258 | biostudies-literature
Project description:BackgroundIn short-term randomized trials (duration, 1 to 2 years), bariatric surgery has been associated with improvement in type 2 diabetes mellitus.MethodsWe assessed outcomes 3 years after the randomization of 150 obese patients with uncontrolled type 2 diabetes to receive either intensive medical therapy alone or intensive medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy. The primary end point was a glycated hemoglobin level of 6.0% or less.ResultsThe mean (±SD) age of the patients at baseline was 48±8 years, 68% were women, the mean baseline glycated hemoglobin level was 9.3±1.5%, and the mean baseline body-mass index (the weight in kilograms divided by the square of the height in meters) was 36.0±3.5. A total of 91% of the patients completed 36 months of follow-up. At 3 years, the criterion for the primary end point was met by 5% of the patients in the medical-therapy group, as compared with 38% of those in the gastric-bypass group (P<0.001) and 24% of those in the sleeve-gastrectomy group (P=0.01). The use of glucose-lowering medications, including insulin, was lower in the surgical groups than in the medical-therapy group. Patients in the surgical groups had greater mean percentage reductions in weight from baseline, with reductions of 24.5±9.1% in the gastric-bypass group and 21.1±8.9% in the sleeve-gastrectomy group, as compared with a reduction of 4.2±8.3% in the medical-therapy group (P<0.001 for both comparisons). Quality-of-life measures were significantly better in the two surgical groups than in the medical-therapy group. There were no major late surgical complications.ConclusionsAmong obese patients with uncontrolled type 2 diabetes, 3 years of intensive medical therapy plus bariatric surgery resulted in glycemic control in significantly more patients than did medical therapy alone. Analyses of secondary end points, including body weight, use of glucose-lowering medications, and quality of life, also showed favorable results at 3 years in the surgical groups, as compared with the group receiving medical therapy alone. (Funded by Ethicon and others; STAMPEDE ClinicalTrials.gov number, NCT00432809.).
| S-EPMC5451259 | biostudies-literature
Project description:BackgroundObservational studies have shown improvement in patients with type 2 diabetes mellitus after bariatric surgery.MethodsIn this randomized, nonblinded, single-center trial, we evaluated the efficacy of intensive medical therapy alone versus medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy in 150 obese patients with uncontrolled type 2 diabetes. The mean (±SD) age of the patients was 49±8 years, and 66% were women. The average glycated hemoglobin level was 9.2±1.5%. The primary end point was the proportion of patients with a glycated hemoglobin level of 6.0% or less 12 months after treatment.ResultsOf the 150 patients, 93% completed 12 months of follow-up. The proportion of patients with the primary end point was 12% (5 of 41 patients) in the medical-therapy group versus 42% (21 of 50 patients) in the gastric-bypass group (P=0.002) and 37% (18 of 49 patients) in the sleeve-gastrectomy group (P=0.008). Glycemic control improved in all three groups, with a mean glycated hemoglobin level of 7.5±1.8% in the medical-therapy group, 6.4±0.9% in the gastric-bypass group (P<0.001), and 6.6±1.0% in the sleeve-gastrectomy group (P=0.003). Weight loss was greater in the gastric-bypass group and sleeve-gastrectomy group (-29.4±9.0 kg and -25.1±8.5 kg, respectively) than in the medical-therapy group (-5.4±8.0 kg) (P<0.001 for both comparisons). The use of drugs to lower glucose, lipid, and blood-pressure levels decreased significantly after both surgical procedures but increased in patients receiving medical therapy only. The index for homeostasis model assessment of insulin resistance (HOMA-IR) improved significantly after bariatric surgery. Four patients underwent reoperation. There were no deaths or life-threatening complications.ConclusionsIn obese patients with uncontrolled type 2 diabetes, 12 months of medical therapy plus bariatric surgery achieved glycemic control in significantly more patients than medical therapy alone. Further study will be necessary to assess the durability of these results. (Funded by Ethicon Endo-Surgery and others; ClinicalTrials.gov number, NCT00432809.).
| S-EPMC3372918 | biostudies-literature
Project description:ImportanceRandomized clinical trials of bariatric surgery have been limited in size, type of surgical procedure, and follow-up duration.ObjectiveTo determine long-term glycemic control and safety of bariatric surgery compared with medical/lifestyle management of type 2 diabetes.Design, setting, and participantsARMMS-T2D (Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes) is a pooled analysis from 4 US single-center randomized trials conducted between May 2007 and August 2013, with observational follow-up through July 2022.InterventionParticipants were originally randomized to undergo either medical/lifestyle management or 1 of the following 3 bariatric surgical procedures: Roux-en-Y gastric bypass, sleeve gastrectomy, or adjustable gastric banding.Main outcome and measuresThe primary outcome was change in hemoglobin A1c (HbA1c) from baseline to 7 years for all participants. Data are reported for up to 12 years.ResultsA total of 262 of 305 eligible participants (86%) enrolled in long-term follow-up for this pooled analysis. The mean (SD) age of participants was 49.9 (8.3) years, mean (SD) body mass index was 36.4 (3.5), 68.3% were women, 31% were Black, and 67.2% were White. During follow-up, 25% of participants randomized to undergo medical/lifestyle management underwent bariatric surgery. The median follow-up was 11 years. At 7 years, HbA1c decreased by 0.2% (95% CI, -0.5% to 0.2%), from a baseline of 8.2%, in the medical/lifestyle group and by 1.6% (95% CI, -1.8% to -1.3%), from a baseline of 8.7%, in the bariatric surgery group. The between-group difference was -1.4% (95% CI, -1.8% to -1.0%; P < .001) at 7 years and -1.1% (95% CI, -1.7% to -0.5%; P = .002) at 12 years. Fewer antidiabetes medications were used in the bariatric surgery group. Diabetes remission was greater after bariatric surgery (6.2% in the medical/lifestyle group vs 18.2% in the bariatric surgery group; P = .02) at 7 years and at 12 years (0.0% in the medical/lifestyle group vs 12.7% in the bariatric surgery group; P < .001). There were 4 deaths (2.2%), 2 in each group, and no differences in major cardiovascular adverse events. Anemia, fractures, and gastrointestinal adverse events were more common after bariatric surgery.Conclusion and relevanceAfter 7 to 12 years of follow-up, individuals originally randomized to undergo bariatric surgery compared with medical/lifestyle intervention had superior glycemic control with less diabetes medication use and higher rates of diabetes remission.Trial registrationClinicalTrials.gov Identifier: NCT02328599.
| S-EPMC10900968 | biostudies-literature
Project description:In this report, we compare weight loss, comorbidity resolution, nutritional abnormalities, and quality of life between younger and older adolescents after metabolic and bariatric surgery. From March 2007 to December 2011, 242 adolescents (≤19 years of age) who underwent bariatric surgery at 5 clinical centers in the United States were enrolled in the prospective, multicenter, long-term outcome study Teen-Longitudinal Assessment of Bariatric Surgery. Outcome data from younger (13-15 years; n = 66) and older (16-19 years; n = 162) study participants were compared. Outcomes included percent BMI change, comorbidity outcomes (hypertension, dyslipidemia, and type 2 diabetes mellitus), nutritional abnormalities, and quality of life over 5 years post surgery. Baseline characteristics, except for age, between the 2 cohorts were similar. No significant differences in frequency of remission of hypertension (P = .84) or dyslipidemia (P = .74) were observed between age groups. Remission of type 2 diabetes mellitus was high in both groups, although statistically higher in older adolescents (relative risk 0.86; P = .046). Weight loss and quality of life were similar in the 2 age groups. Younger adolescents were less likely to develop elevated transferrin (prevalence ratio 0.52; P = .048) and low vitamin D levels (prevalence ratio 0.8; P = .034). The differences in outcome of metabolic and bariatric surgery between younger and older adolescents were few. These data suggest that younger adolescents with severe obesity should not be denied consideration for surgical therapy on the basis of age alone and that providers should consider adolescents of all ages for surgical therapy for obesity when clinically indicated.
| S-EPMC7919111 | biostudies-literature
Project description:ObjectiveTo 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.BackgroundThere are few studies comparing surgery to MWM for patients with T2DM and BMI less than 35.MethodsFifty-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.ResultsThe 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.ConclusionsSurgery 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.
| S-EPMC4691842 | biostudies-literature
Project description:Many individuals with short bowel syndrome (SBS) require long-term parenteral nutrition (PN) to maintain adequate nutritional status. Herein, we report a successful intestinal adaptation of a patient with SBS through 13 times intensive nutritional support team (NST) managements. A thirty-five-year-old woman who could not eat due to intestinal discontinuity visited Seoul National University Hospital for reconstruction of the bowel. She received laparoscopic Roux-en-Y gastric bypass (RYGB) due to morbid obesity in Jan 2013 at a certain hospital and successfully reduced her weight from 110 kg to 68 kg. However, after a delivery of the second baby by cesarean section in Jul 2016, most of small bowel was herniated through Peterson's defect, and emergent massive small bowel resection was performed. Thereafter, she visited our hospital for the purpose of intestinal reconstruction. In Sep 2016, she received side-to-side gastrogastrostomy and revision of double barrel enterostomy. The remaining small bowel included whole duodenum, 30 cm of proximal jejunum, and 10 cm of terminal ileum. Pylorus and ileocecal valves were intact. The patient given only PN after surgery was provided rice-based soft fluid diet after 10 day of operation. Through intensive nutritional management care, she could start solid meals, and finally stop the PN and eat only orally at 45 days postoperatively. Three nutritional interventions were conducted over 2 months after the patient was discharged. She did not require PN during this period, and maintained her weight within the normal weight range. Similar interventions could be used for other patients with malabsorption problems similar to SBS.
| S-EPMC5539216 | biostudies-other
Project description:Projection of gut microbiome pre and post bariatric surgery to predict surgery outcome
| PRJEB39382 | ENA
Project description:Effect of bariatric surgery on microbiome composition and microbial metabolomics.
| PRJEB28869 | ENA
Project description:Bariatric surgery Targeted loci environmental
| PRJNA1041054 | ENA