Dataset Information

Type 2 diabetes remission 1?year after an intensive lifestyle intervention: A secondary analysis of a randomized clinical trial.

ABSTRACT: AIM:To investigate whether an intensive lifestyle intervention induces partial or complete type 2 diabetes (T2D) remission. MATERIALS AND METHODS:In a secondary analysis of a randomized, assessor-blinded, single-centre trial, people with non-insulin-dependent T2D (duration <10?years), were randomly assigned (2:1, stratified by sex, from April 2015 to August 2016) to a lifestyle intervention group (n = 64) or a standard care group (n = 34). The primary outcome was partial or complete T2D remission, defined as non-diabetic glycaemia with no glucose-lowering medication at the outcome assessments at both 12 and 24?months from baseline. All participants received standard care, with standardized, blinded, target-driven medical therapy during the initial 12?months. The lifestyle intervention included 5- to 6-weekly aerobic and combined aerobic and strength training sessions (30-60?minutes) and individual dietary plans aiming for body mass index ?25?kg/m2 . No intervention was provided during the 12-month follow-up period. RESULTS:Of the 98 randomized participants, 93 completed follow-up (mean [SD] age 54.6 [8.9] years; 46 women [43%], mean [SD] baseline glycated haemoglobin 49.3 [9.3] mmol/mol). At follow-up, 23% of participants (n = 14) in the intervention and 7% (n = 2) in the standard care group met the criteria for any T2D remission (odds ratio [OR] 4.4, 95% confidence interval [CI] 0.8-21.4]; P = 0.08). Assuming participants lost to follow-up (n = 5) had relapsed, the OR for T2D remission was 4.4 (95% CI 1.0-19.8; P = 0.048). CONCLUSIONS:The statistically nonsignificant threefold increased remission rate of T2D in the lifestyle intervention group calls for further large-scale studies to understand how to implement sustainable lifestyle interventions among people with T2D.

SUBMITTER: Ried-Larsen M

PROVIDER: S-EPMC6772176 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Type 2 diabetes remission 1 year after an intensive lifestyle intervention: A secondary analysis of a randomized clinical trial.

Ried-Larsen Mathias M Johansen Mette Y MY MacDonald Christopher S CS Hansen Katrine B KB Christensen Robin R Wedell-Neergaard Anne-Sophie AS Pilmark Nanna Skytt NS Langberg Henning H Vaag Allan A AA Pedersen Bente K BK Karstoft Kristian K

Diabetes, obesity & metabolism 20190630 10

<h4>Aim</h4>To investigate whether an intensive lifestyle intervention induces partial or complete type 2 diabetes (T2D) remission.<h4>Materials and methods</h4>In a secondary analysis of a randomized, assessor-blinded, single-centre trial, people with non-insulin-dependent T2D (duration <10 years), were randomly assigned (2:1, stratified by sex, from April 2015 to August 2016) to a lifestyle intervention group (n = 64) or a standard care group (n = 34). The primary outcome was partial or comple ...[more]

PMID: 31168922

Similar Datasets

Project description:The frequency of remission of type 2 diabetes achievable with lifestyle intervention is unclear.To examine the association of a long-term intensive weight-loss intervention with the frequency of remission from type 2 diabetes to prediabetes or normoglycemia.Ancillary observational analysis of a 4-year randomized controlled trial (baseline visit, August 2001-April 2004; last follow-up, April 2008) comparing an intensive lifestyle intervention (ILI) with a diabetes support and education control condition (DSE) among 4503 US adults with body mass index of 25 or higher and type 2 diabetes.Participants were randomly assigned to receive the ILI, which included weekly group and individual counseling in the first 6 months followed by 3 sessions per month for the second 6 months and twice-monthly contact and regular refresher group series and campaigns in years 2 to 4 (n=2241) or the DSE, which was an offer of 3 group sessions per year on diet, physical activity, and social support (n=2262).Partial or complete remission of diabetes, defined as transition from meeting diabetes criteria to a prediabetes or nondiabetic level of glycemia (fasting plasma glucose <126 mg/dL and hemoglobin A1c <6.5% with no antihyperglycemic medication). RESULTS Intensive lifestyle intervention participants lost significantly more weight than DSE participants at year 1 (net difference, -7.9%; 95% CI, -8.3% to -7.6%) and at year 4 (-3.9%; 95% CI, -4.4% to -3.5%) and had greater fitness increases at year 1 (net difference, 15.4%; 95% CI, 13.7%-17.0%) and at year 4 (6.4%; 95% CI, 4.7%-8.1%) (P < .001 for each). The ILI group was significantly more likely to experience any remission (partial or complete), with prevalences of 11.5% (95% CI, 10.1%-12.8%) during the first year and 7.3% (95% CI, 6.2%-8.4%) at year 4, compared with 2.0% for the DSE group at both time points (95% CIs, 1.4%-2.6% at year 1 and 1.5%-2.7% at year 4) (P < .001 for each). Among ILI participants, 9.2% (95% CI, 7.9%-10.4%), 6.4% (95% CI, 5.3%-7.4%), and 3.5% (95% CI, 2.7%-4.3%) had continuous, sustained remission for at least 2, at least 3, and 4 years, respectively, compared with less than 2% of DSE participants (1.7% [95% CI, 1.2%-2.3%] for at least 2 years; 1.3% [95% CI, 0.8%-1.7%] for at least 3 years; and 0.5% [95% CI, 0.2%-0.8%] for 4 years).In these exploratory analyses of overweight adults, an intensive lifestyle intervention was associated with a greater likelihood of partial remission of type 2 diabetes compared with diabetes support and education. However, the absolute remission rates were modest. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00017953.

Project description:It is unclear whether a lifestyle intervention can maintain glycemic control in patients with type 2 diabetes.To test whether an intensive lifestyle intervention results in equivalent glycemic control compared with standard care and, secondarily, leads to a reduction in glucose-lowering medication in participants with type 2 diabetes.Randomized, assessor-blinded, single-center study within Region Zealand and the Capital Region of Denmark (April 2015-August 2016). Ninety-eight adult participants with non-insulin-dependent type 2 diabetes who were diagnosed for less than 10 years were included. Participants were randomly assigned (2:1; stratified by sex) to the lifestyle group (n?=?64) or the standard care group (n?=?34).All participants received standard care with individual counseling and standardized, blinded, target-driven medical therapy. Additionally, the lifestyle intervention included 5 to 6 weekly aerobic training sessions (duration 30-60 minutes), of which 2 to 3 sessions were combined with resistance training. The lifestyle participants received dietary plans aiming for a body mass index of 25 or less. Participants were followed up for 12 months.Primary outcome was change in hemoglobin A1c (HbA1c) from baseline to 12-month follow-up, and equivalence was prespecified by a CI margin of ±0.4% based on the intention-to-treat population. Superiority analysis was performed on the secondary outcome reductions in glucose-lowering medication.Among 98 randomized participants (mean age, 54.6 years [SD, 8.9]; women, 47 [48%]; mean baseline HbA1c, 6.7%), 93 participants completed the trial. From baseline to 12-month follow-up, the mean HbA1c level changed from 6.65% to 6.34% in the lifestyle group and from 6.74% to 6.66% in the standard care group (mean between-group difference in change of -0.26% [95% CI, -0.52% to -0.01%]), not meeting the criteria for equivalence (P?=?.15). Reduction in glucose-lowering medications occurred in 47 participants (73.5%) in the lifestyle group and 9 participants (26.4%) in the standard care group (difference, 47.1 percentage points [95% CI, 28.6-65.3]). There were 32 adverse events (most commonly musculoskeletal pain or discomfort and mild hypoglycemia) in the lifestyle group and 5 in the standard care group.Among adults with type 2 diabetes diagnosed for less than 10 years, a lifestyle intervention compared with standard care resulted in a change in glycemic control that did not reach the criterion for equivalence, but was in a direction consistent with benefit. Further research is needed to assess superiority, as well as generalizability and durability of findings.clinicaltrials.gov Identifier: NCT02417012.

Project description:ImportanceQuestions remain about the role and durability of bariatric surgery for type 2 diabetes mellitus (T2DM).ObjectiveTo compare the remission of T2DM following surgical and nonsurgical treatments.Design, setting, and participantsIn this 3-arm randomized clinical trial conducted at the University of Pittsburgh Medical Center from October 1, 2009, to June 26, 2014, in Pittsburgh, Pennsylvania, outcomes were assessed 3 years after treating 61 obese participants aged 25 to 55 years with T2DM. Analysis was conducted with an intent-to-treat population.InterventionsParticipants were randomized to either an intensive lifestyle weight loss intervention for 1 year followed by a low-level lifestyle intervention for 2 years or surgical treatments (Roux-en-Y gastric bypass [RYGB] or laparoscopic adjustable gastric banding [LAGB]) followed by low-level lifestyle intervention in years 2 and 3.Main outcomes and measuresPrimary end points were partial and complete T2DM remission and secondary end points included diabetes medications and weight change.ResultsBody mass index (calculated as weight in kilograms divided by height in meters squared) was less than 35 for 26 participants (43%), 50 (82%) were women, and 13 (21%) were African American. Mean (SD) values were 100.5 (13.7) kg for weight, 47.3 (6.6) years for age, 7.8% (1.9%) for hemoglobin A1c level, and 171.3 (72.5) mg/dL for fasting plasma glucose level. Partial or complete T2DM remission was achieved by 40% (n = 8) of RYGB, 29% (n = 6) of LAGB, and no intensive lifestyle weight loss intervention participants (P = .004). The use of diabetes medications was reduced more in the surgical groups than the lifestyle intervention-alone group, with 65% of RYGB, 33% of LAGB, and none of the intensive lifestyle weight loss intervention participants going from using insulin or oral medication at baseline to no medication at year 3 (P < .001). Mean (SE) reductions in percentage of body weight at 3 years were the greatest after RYGB at 25.0% (2.0%), followed by LAGB at 15.0% (2.0%) and lifestyle treatment at 5.7% (2.4%) (P < .01).Conclusions and relevanceAmong obese participants with T2DM, bariatric surgery with 2 years of an adjunctive low-level lifestyle intervention resulted in more disease remission than did lifestyle intervention alone.Trial registrationclinicaltrials.gov Identifier: NCT01047735.

Project description:Background: The Republic of the Marshall Islands has the highest prevalence of type 2 diabetes (T2D) in the world, with the country's rapid rise of T2D attributed to its reliance on imported and refined foods laden with salt, sugar, and fat. As much as lifestyle factors can increase the risk of T2D, they can also reverse or treat the disease, with multiple studies demonstrating that plant-based diets and/or moderate exercise improve glycemic control and cardiovascular risk factors in T2D patients. Objective: We therefore tested the hypothesis that a community-based, intensive, plant-rich lifestyle intervention with exercise is more effective for treating and managing T2D in the Republic of the Marshall Islands than the standard of diabetes care. Methods: Building on a successful lifestyle program used at the Guam Seventh-day Adventist Clinic, we conducted a randomized controlled trial to test the effectiveness of an intensive lifestyle intervention involving a plant-rich diet and moderate exercise or the standard of care in T2D patients for 24 weeks. In this manuscript, we describe the clinical trial protocol, including the rationale, design, and methods of the clinical trial and the lifestyle program. The lifestyle intervention included a step-wise, intensive 12-week program of counseling and instruction on healthy eating, exercise, and stress management. The prescribed diet focused on high-fiber, whole plant foods, with foods grouped into a four-tiered system. The lifestyle intervention also involved hands-on cooking classes, meals prepared for participants, and group exercise classes-all tailored to be culturally appropriate. The study's main endpoints were glycemic control and cardiovascular disease risk factors. Discussion: The present study is the first randomized clinical trial conducted in the Republic of the Marshall Islands and the first lifestyle intervention trial conducted in Micronesia. The results of this study will help guide future medical care for indigenous populations in the Pacific Islands and will also shed light on how to effectively design and deliver intensive lifestyle interventions to treat and manage diabetes. Clinical Trials Registration: www.ClinicalTrials.gov; identifier NCT03862963.

Project description:Aims/hypothesisMounting evidence indicates that Roux-en-Y gastric bypass (RYGB) ameliorates type 2 diabetes, but randomised trials comparing surgical vs nonsurgical care are needed. With a parallel-group randomised controlled trial (RCT), we compared RYGB vs an intensive lifestyle and medical intervention (ILMI) for type 2 diabetes, including among patients with a BMI <35 kg/m(2).MethodsBy use of a shared decision-making recruitment strategy targeting the entire at-risk population within an integrated community healthcare system, we screened 1,808 adults meeting inclusion criteria (age 25-64, with type 2 diabetes and a BMI 30-45 kg/m(2)). Of these, 43 were allocated via concealed, computer-generated random assignment in a 1:1 ratio to RYGB or ILMI. The latter involved ≥45 min of aerobic exercise 5 days per week, a dietitian-directed weight- and glucose-lowering diet, and optimal diabetes medical treatment for 1 year. Although treatment allocation could not be blinded, outcomes were determined by a blinded adjudicator. The primary outcome was diabetes remission at 1 year (HbA1c <6.0% [<42.1 mmol/mol], off all diabetes medicines).ResultsTwenty-three volunteers were assigned to RYGB and 20 to ILMI. Of these, 11 withdrew before receiving any intervention. Hence 15 in the RYGB group and 17 in the IMLI group were analysed throughout 1 year. The groups were equivalent regarding all baseline characteristics, except that the RYGB cohort had a longer diabetes duration (11.4 ± 4.8 vs 6.8 ± 5.2 years, p = 0.009). Weight loss at 1 year was 25.8 ± 14.5% vs 6.4 ± 5.8% after RYGB vs ILMI, respectively (p < 0.001). The ILMI exercise programme yielded a 22 ± 11% increase in [Formula: see text] (p<0.0001), whereas [Formula: see text] after RYGB was unchanged. Diabetes remission at 1 year was 60.0% with RYGB vs 5.9% with ILMI (p = 0.002). The HbA1c decline over 1 year was only modestly more after RYGB than ILMI: from 7.7 ± 1.0% (60.7 mmol/mol) to 6.4 ± 1.6% (46.4 mmol/mol) vs 7.3 ± 0.9% (56.3 mmol/mol) to 6.9 ± 1.3% (51.9 mmol/mol), respectively (p = 0.04); however, this drop occurred with significantly fewer or no diabetes medications after RYGB. No life-threatening complications occurred.Conclusions/interpretationCompared with the most rigorous ILMI yet tested against surgery in a randomised trial, RYGB yielded greater type 2 diabetes remission in mild-to-moderately obese patients recruited from a well-informed, population-based sample.Trial registrationClinicalTrials.gov NCT01295229.

Project description:ObjectivesThere is growing evidence that type 2 diabetes (T2D) can be put into remission through lifestyle intervention. Current focus on remission in terms of physiological considerations and biomedical scales, means there is limited understanding of the role psycho-social factors play in moderating the efficacy of lifestyle interventions for T2D remission. In the current review we aimed to synthesise the emerging literature on psycho-social factors associated with T2D remission, specifically from lifestyle interventions.MethodsFive databases (EMBASE, MEDLINE, CINAHL ultimate, PsychINFO and PsycArticles) were searched to identify studies from 2009 onwards that reported remission outcomes from lifestyle interventions in participants ≥ 18years old, with a clinical diagnosis of T2D. Studies included were of an interventional or observational design and restricted to English language. Screening and data extraction was performed independently by two reviewers using prespecified criteria.ResultsIn total 6106 studies were screened, 36 studies meeting the inclusion criteria were included. Studies were globally diverse, with 30 (83%) being published ≥ 2017. Psycho-social scales were under-utilised with 22 (67%) of studies failing to include any psycho-social measures. Single arm, prospective studies were most frequently utilised, however study quality was perceived to be heterogeneous. Further disparity in the quality, content and delineation of the psycho-social interventions was also identified. Education and self-monitoring interventions were the most frequently incorporated. Self-monitoring was also identified as an important facilitator to remission, in addition to social support.ConclusionsOur findings indicate that psycho-social factors in T2D remission are under-explored. We have identified a number of methodological issues (comparability, conflicting remission criteria and poorly defined psycho-social interventions) suggesting knowledge gaps which could inform the methodology of future research design. There is significant opportunity for future research to incorporate the social model of disease, conceptualise remission more holistically, and build a more comprehensive evidence base to guide clinical practice.

Dataset Information

Type 2 diabetes remission 1?year after an intensive lifestyle intervention: A secondary analysis of a randomized clinical trial.

Publications

Type 2 diabetes remission 1 year after an intensive lifestyle intervention: A secondary analysis of a randomized clinical trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets