Evidence map›Paper›PMID 26193177›Full record

Trial reportObesity (Silver Spring, Md.)2015

Two-year outcomes on bone density and fracture incidence in patients with T2DM randomized to bariatric surgery versus intensive medical therapy.

Adam H Maghrabi, Kathy Wolski, Beth Abood, Angelo Licata, Claire Pothier, Deepak L Bhatt, Steven Nissen, Stacy A Brethauer, John P Kirwan, Philip R Schauer and 1 more

Registry-linked trialOpen access · bronzeAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Obesity (Silver Spring, Md.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03339791 (Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass for Treatment of Severe Obesity in Patients With 65 Years or Older), which is not on this map. Cited by 44 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 7 pooled it
11.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03339791 nacompletednot on this mapstarted 2017, after this paper: background citation

Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass for Treatment of Severe Obesity in Patients With 65 Years or Older: a Randomized Controlled Trial - The "BaSE" Trial - Bariatric Surgery in the Elderly.

TypeinterventionalSponsorUniversity of Sao Paulo General HospitalRan2017 to 2019Enrolled36ConditionsObesity, Morbid, Surgery, ElderlyArmsSleeve Gastrectomy, Gastric Bypass
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 7 syntheses or guidelines pooled it, 105 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Fracture risk following bariatric surgery: a systematic review and meta-analysis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2022
    Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Trial
  9. Trial
  10. Trial
  11. Review
  12. Article
  13. Article
  14. Observational
  15. Article
  16. Article
  17. Biochemical Markers of Bone Fragility in Patients with DiabetesThe Journal of clinical endocrinology and metabolism · 2023
    Article
  18. Observational
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 2 institutions in 1 country.

Adam H MaghrabiInstitutes of Clinical Nutrition and Gastroenterology, The Cleveland Clinic, Ohio, USA.
Kathy WolskiHeart and Vascular Institute, The Cleveland Clinic, Cleveland, Ohio.
Beth AboodEndocrinology and Metabolism Institute, The Cleveland Clinic, Ohio, USA.
Angelo LicataEndocrinology and Metabolism Institute, The Cleveland Clinic, Ohio, USA.
Claire PothierHeart and Vascular Institute, The Cleveland Clinic, Cleveland, Ohio.
Deepak L BhattInstitutes of Clinical Nutrition and Gastroenterology, The Cleveland Clinic, Ohio, USA.
Steven NissenHeart and Vascular Institute, The Cleveland Clinic, Cleveland, Ohio.
Stacy A BrethauerBariatric and Metabolic Institute, The Cleveland Clinic, Ohio, USA.
John P KirwanLerner Research, The Cleveland Clinic, Ohio, USA.
Philip R SchauerBariatric and Metabolic Institute, The Cleveland Clinic, Ohio, USA.
Sangeeta R KashyapEndocrinology and Metabolism Institute, The Cleveland Clinic, Ohio, USA.
Cleveland Clinic · USBrigham and Women's Hospital · US

Funding

Clinical and Translational Science Collaborative of ClevelandUL1TR000439 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI KONSTAN, MICHAEL W. · 2012 to 2016
$50.0M
Effect of Bariatric Surgery on Mechanisms of Type 2 Diabetes: The B2D TrialR01DK089547 · NIDDK · CLEVELAND CLINIC LERNER COM-CWRU · PI KASHYAP, SANGEETA R, KIRWAN, JOHN P. · 2010 to 2013
$1.9M
NCATS NIH HHS UL1 TR000439NIDDK NIH HHS R01 DK089547
6 · The paper itself

Abstract

objectiveTo determine the 2-year outcomes of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) vs. intensive medical therapy (IMT) on lean body mass, total bone mass, and bone mineral density (BMD) measures from the STAMPEDE trial.

methods54 subjects (BMI: 36 ± 1 kg/m(2) , age: 48 ± 4 years) with type 2 diabetes (T2DM) (HbA1c : 9.7 ± 2%) were randomized to IMT, RYGB, or SG and underwent DXA at baseline and at 1 and 2 years.

resultsAt 2 years, the reduction in BMI was similar after RYGB and SG and was greater than IMT (P < 0.001). Lean mass was reduced by ∼10%, total bone mineral content reduced by ∼8%, and hip BMD reduced by ∼9% in both surgical groups and was significantly greater than IMT despite increases in vitamin D intake in all groups. The change in hip BMD correlated with weight loss (r = 0.84, P < 0.0001) and changes in lean mass (r = 0.74, P < 0.0001) and leptin (r = 0.53, P < 0.0001). Peripheral fractures were self-reported in RYGB (4/18 patients), SG (2/19 patients), and IMT (4/16 patients).

conclusionsSurgically induced weight loss is associated with modest reductions in lean mass, bone mineral content, and BMD, despite calcium and vitamin D supplementation in patients with T2DM. Awareness for bone loss is indicated for patients undergoing bariatric procedures.

Indexed as

Bariatric SurgeryBone DensityAdultBody CompositionDiabetes Mellitus, Type 2FemaleFollow-Up StudiesFractures, BoneHumansHypoglycemic AgentsIncidenceMaleMiddle AgedTreatment OutcomeHypoglycemic Agents

Identifiers

PMID26193177
PMCPMC4701611
OpenAlexW2127191832

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.