{"doi":"10.1111/dom.14680","title":"Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes (ARMMS‐T2D): Study rationale, design, and methods","abstract":"Abstract Aims Long‐term data from randomized clinical trials comparing metabolic (bariatric) surgery versus a medical/lifestyle intervention for treatment of patients with obesity/overweight and type 2 diabetes (T2D) are lacking. The Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes (ARMMS‐T2D) is a consortium of four randomized trials designed to compare long‐term efficacy and safety of surgery versus medical/lifestyle therapy on diabetes control and clinical outcomes. Materials and Methods Patients with T2D and body mass index (BMI) of 27‐45 kg/m 2 who were previously randomized to metabolic surgery (Roux‐en‐Y gastric bypass, adjustable gastric band, or sleeve gastrectomy) versus medical/lifestyle intervention in the STAMPEDE, SLIMM‐T2D, TRIABETES, or CROSSROADS trials have been enrolled in ARMMS‐T2D for observational follow‐up. The primary outcome is change in glycated haemoglobin after a minimum 7 years of follow‐up, with additional analyses to determine rates of diabetes remission and relapse, as well as cardiovascular and renal endpoints. Results In total, 302 patients (192 surgical, 110 medical/lifestyle) previously randomized in the four parent studies were eligible for participation in the ARMMS‐T2D observational study. Participant demographics were 71% white, 27% African‐American and 68% female. At baseline: age, 50 ± 8 years; BMI, 36.5 ± 3.5 kg/m 2 ; duration of diabetes, 8.8 ± 5.6 years; glycated haemoglobin, 8.6% ± 1.6%; and fasting glucose, 168 ± 64 mg/dl. More than 35% of patients had a BMI <35 kg/m 2 . Conclusions ARMMS‐T2D will provide the largest body of long‐term, level 1 evidence to inform clinical decision‐making regarding the comparative durability, efficacy and safety of metabolic surgery relative to a medical/lifestyle intervention among patients with T2D, including those with milder class I obesity or mere overweight.","journal":"Diabetes Obesity and Metabolism","year":2022,"id":281182,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":8,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.5144,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2022-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":455368,"name":"Bo Hu","orcid":"0000-0003-0606-7639","position":1,"is_corresponding":false},{"id":251523,"name":"David Arterburn","orcid":"0000-0002-5208-8492","position":2,"is_corresponding":false},{"id":107049,"name":"Philip R. Schauer","orcid":"0000-0002-4029-7537","position":3,"is_corresponding":false},{"id":460702,"name":"Sangeeta R. Kashyap","orcid":"0000-0002-7489-6650","position":4,"is_corresponding":false},{"id":31468,"name":"Anita P. Courcoulas","orcid":"0000-0002-4973-7869","position":5,"is_corresponding":false},{"id":107044,"name":"David E. Cummings","orcid":null,"position":6,"is_corresponding":false},{"id":53898,"name":"Mary‐Elizabeth Patti","orcid":"0000-0002-8163-3429","position":7,"is_corresponding":false},{"id":31467,"name":"William Gourash","orcid":"0000-0001-6824-0631","position":8,"is_corresponding":false},{"id":504192,"name":"Ashley H. Vernon","orcid":null,"position":9,"is_corresponding":false},{"id":235351,"name":"John M. Jakicic","orcid":"0000-0001-6800-9368","position":10,"is_corresponding":false},{"id":107063,"name":"John P. Kirwan","orcid":"0000-0001-7321-9917","position":11,"is_corresponding":false},{"id":956034,"name":"Donald C. Simonson","orcid":"0000-0002-4670-6290","position":0,"is_corresponding":true}],"reference_count":41,"raw_metadata":null,"created_at":"2026-07-19T00:29:07.472902Z","pmid":"35233923","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}