***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: BACKGROUND / OBJECTIVE Very low-carbohydrate , high-fat ( LC ) diets are used for type 2 diabetes ( T2DM ) management , but their effects on psychological health remain largely unknown . This study examined the long-term effects of an LC diet on psychological health . METHODS One hundred and fifteen obese adults [ age : 58.5 ± 7.1 years ; body mass index : 34.6 ± 4.3 kg m(-2 ) ; HbA1c : 7.3 ± 1.1 % ] with T2DM were r and omized to consume either an energy-restricted ( ~6 to 7 MJ ) , planned isocaloric LC or high-carbohydrate , low-fat ( HC ) diet , combined with a supervised exercise programme ( 3 days week(-1 ) ) for 1 year . Body weight , psychological mood state and well-being [ Profile of Mood States ( POMS ) , Beck Depression Inventory ( BDI ) and Spielberger State Anxiety Inventory ( SAI ) ] and diabetes-specific emotional distress [ Problem Areas in Diabetes ( PAID ) Question naire ] and quality of life [ QoL Diabetes-39 ( D-39 ) ] were assessed . RESULTS Overall weight loss was 9.5 ± 0.5 kg ( mean ± SE ) , with no difference between groups ( P = 0.91 time × diet ) . Significant improvements occurred in BDI , POMS ( total mood disturbance and the six subscales of anger-hostility , confusion-bewilderment , depression-dejection , fatigue-inertia , vigour-activity and tension-anxiety ) , PAID ( total score ) and the D-39 dimensions of diabetes control , anxiety and worry , sexual functioning and energy and mobility , P < 0.05 time . SAI and the D-39 dimension of social burden remained unchanged ( P ≥ 0.08 time ) . Diet composition had no effect on the responses for the outcomes assessed ( P ≥ 0.22 time × diet ) . CONCLUSION In obese adults with T2DM , both diets achieved substantial weight loss and comparable improvements in QoL , mood state and affect . These results suggest that either an LC or HC diet within a lifestyle modification programme that includes exercise training improves psychological well-being The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement aims to improve the reporting of r and omized controlled trials ( RCTs ) ; however , it lacks guidance on the reporting of patient-reported outcomes ( PROs ) , which are often inadequately reported in trials , thus limiting the value of these data . In this article , we describe the development of the CONSORT PRO extension based on the method ological framework for guideline development proposed by the Enhancing the Quality and Transparency of Health Research ( EQUATOR ) Network . Five CONSORT PRO checklist items are recommended for RCTs in which PROs are primary or important secondary end points . These recommendations urge that the PROs be identified as a primary or secondary outcome in the abstract , that a description of the hypothesis of the PROs and relevant domains be provided ( ie , if a multidimensional PRO tool has been used ) , that evidence of the PRO instrument 's validity and reliability be provided or cited , that the statistical approaches for dealing with missing data be explicitly stated , and that PRO-specific limitations of study findings and generalizability of results to other population s and clinical practice be discussed . Examples and an up date d CONSORT flow diagram with PRO items are provided . It is recommended that the CONSORT PRO guidance supplement the st and ard CONSORT guidelines for reporting RCTs with PROs as primary or secondary outcomes . Improved reporting of PRO data should facilitate robust interpretation of the results from RCTs and inform patient care Purpose The purpose of the study was to examine the impact of a 12-month weight loss intervention with either a low-carbohydrate or a low-fat diet on quality of life ( QOL ) among obese patients with type 2 diabetes . Methods Participants were enrolled in a r and omized trial comparing a low-carbohydrate to a low-fat diet in type 2 diabetes . QOL was assessed with the Diabetes-39 question naire , which measures QOL within 5 distinct scales : anxiety and worry , diabetes control , energy and mobility , social burden , and sexual functioning . Repeated measures ANOVA compared change in QOL scales at baseline and 6 and 12 months . Results Forty-six participants completed all measures . Following 12 months , there was a significant reduction in the scores related to sexual function and energy and mobility , suggesting improvement in QOL related to these domains . These changes were not significantly different between dietary arms . Changes in weight , A1C , and dietary composition were not significantly correlated with changes in QOL . Conclusions Participants with diabetes have various options for weight loss . Dietary interventions with either low-carbohydrate or low-fat diets may lead to some improvements in QOL in patients with type 2 diabetes Aims /hypothesisWeight-loss programmes for adults with type 2 diabetes are less effective in the long term owing to regain of weight . Our aim was to determine the 2 year effectiveness of a cognitive behavioural group therapy ( group-CBT ) programme in weight maintenance after diet-induced weight loss in overweight and obese adults with type 2 diabetes , using a r and omised , parallel , non-blinded , pragmatic study design . Methods We included 158 obese adults ( median BMI 36.3 [ IQR 32.5–40.0 ] kg/m2 ) with type 2 diabetes from the outpatient diabetes clinic of Erasmus MC , the Netherl and s , who achieved ≥5 % weight loss on an 8 week very low calorie diet .  Participants were r and omised ( stratified by weight loss ) to usual care or usual care plus group-CBT ( 17 group sessions ) . The primary outcomes were the between-group differences after 2 years in : ( 1 ) body weight ; and ( 2 ) weight regain . Secondary outcomes were HbA1c levels , insulin dose , plasma lipid levels , depression , anxiety , self-esteem , quality of life , fatigue , physical activity , eating disorders and related cognitions . Data were analysed using linear mixed modelling . Results During the initial 8 week dieting phase , the control group ( n = 75 ) lost a mean of 10.0 ( 95 % CI 9.1 , 10.9 ) kg and the intervention group ( n = 83 ) lost 9.2 ( 95 % CI 8.4 , 10.0 ) kg ( p = 0.206 for the between-group difference ) . During 2 years of follow-up , mean weight regain was 4.7 ( 95 % CI 3.0 , 6.3 ) kg for the control group and 4.0 ( 95 % CI 2.3 , 5.6 ) kg for the intervention group , with a between-group difference of −0.7 ( 95 % CI −3.1 , 1.6 ) kg ( p = 0.6 ) . The mean difference in body weight at 2 years was −1.2 ( 95 % CI −7.7 , 5.3 ) kg ( p = 0.7 ) . None of the secondary outcomes differed between the two groups . Conclusions /interpretationDespite increased treatment contact , a group-CBT programme for long-term weight maintenance after an initial ≥5 % weight loss from dieting in obese individuals with type 2 diabetes was not superior to usual care alone . Trial registration Trialregister.nl NTR2264 Funding The study was funded by the Erasmus MC funding programme ‘ Zorgonderzoek ’ ( grant 2008 - 8303 ) AIMS Type 2 diabetes mellitus ( T2DM ) can substantially decrease quality of life ( QOL ) . This study examined the effects on QOL-relevant psychosocial measures of a widely available commercial weight loss program enhanced for individuals with T2DM . METHODS A year-long multi-site r and omized clinical trial compared the Weight Watchers ( WW ) approach , supplemented with phone and email counseling with a certified diabetes educator ( CDE ) , to brief st and ard diabetes nutrition counseling and education ( St and ard Care ; SC ) . Participants were 400 women and 163 men ( N=279 WW ; 284 SC ) with T2DM [ mean ( ±SD ) HbA1c 8.32±1 % ; BMI = 37.1±5.7kg/m2 ; age=55.1 ± 9.1years ] . Psychosocial outcomes were assessed at baseline , month 6 , and month 12 using a diabetes specific psychosocial measure ( Diabetes Distress Scale [ DDS ] ) , Impact of Weight on Quality of Life-Lite scale ( IWQOL ) , a generic QOL measure ( SF-36 ) , and a depression screen ( PHQ-9 ) . RESULTS WW participants showed significantly greater improvements than did SC participants on all DDS subscales and total score and on IWQOL total score and physical function , sex life and work domains ( all ps<.05 ) . There was no significant treatment effect on SF-36 scores or PHQ-9 . CONCLUSIONS WW enhanced for individuals with T2DM was superior to SC in improving psychosocial outcomes most specific to T2DM and obesity . Available commercial WL programs , combined with scalable complementary program-specific diabetes counseling , may have benefits that extend to diabetes-related distress and weight-relevant QOL BACKGROUND Compared with adults without type 2 diabetes mellitus , those with the disease experience more limitations in their physical functioning ( PF ) . Look AHEAD is a large multicenter trial that examined the effects of an intensive lifestyle intervention ( ILI ) for weight loss on cardiovascular outcomes compared with diabetes support and education ( DSE ) . Although the current study compared treatment differences between ILI and DSE on PF , the primary goal was to examine whether this effect was moderated by age and history of cardiovascular disease at enrollment . METHODS Overweight or obese adults with type 2 diabetes mellitus ( n = 5,145 ) were r and omly assigned to either ILI or DSE .  The mean ( ±SD ) age and % females in ILI was 58.9 years ( ±6.9 ) and 59.8 % ; it was 58.6 years ( 6.8 ) and 59.5 % in DSE . Analysis in 4,998 participants assessed the differential rates of decline in PF across a period of 8 years for the ILI and DSE groups . RESULTS ILI result ed in improved PF  compared with DSE after 1 year ( p < .0001 ) and was maintained across time . Within the ILI , older adults experienced greater improvements than younger adults ( p < .0001 ) . By year 2 , persons in ILI with preexisting cardiovascular disease were no different in PF than in DSE participants with preexisting cardiovascular disease . CONCLUSION With the exception of persons who had a history of cardiovascular disease  , ILI slowed the decline in PF with type 2 diabetes mellitus despite weight regain , an effect that was stronger for older than younger participants and could translate into reductions in falls and disability Aims /hypothesisLong-term trials in insulin-treated subjects with type 2 diabetes have shown that adjunctive treatment with the amylin analogue pramlintide reduces HbA1c levels and elicits weight loss . While amylin reduces food intake in rodents , pramlintide ’s effect on satiety and food intake in humans has not yet been assessed . Methods In this r and omised , double-blind , placebo-controlled crossover study , 11 insulin-treated men with type 2 diabetes ( age 60±9 years , BMI 28.9±4.8 kg/m2 ) and 15 non-diabetic obese men ( age 41±21 years , BMI 34.4±4.5 kg/m2 ) underwent two st and ardised meal tests  . After fasting overnight , subjects received single subcutaneous injections of either pramlintide ( 120 μg ) or placebo , followed by a preload meal . After 1 h , subjects ate an ad libitum buffet meal . Energy intake and meal duration were measured , as were hunger ratings ( using visual analogue scales ) , and plasma cholecystokinin , glucagon-like peptide-1 and peptide YY concentrations over time . Results Compared with placebo , pramlintide  reduced energy intake in both the type 2 diabetes ( Δ−202±64 kcal , −23±8 % , p<0.01 ) and obese ( Δ−170±68 kcal , −16±6 % , p<0.02 ) groups , without affecting meal duration . Hunger and hormonal analyte profiles provided evidence that pramlintide may exert a primary satiogenic effect , independently of other anorexigenic gut peptides . Conclusions /interpretationThe results indicate that enhanced satiety and reduced food intake may explain the weight loss observed in long-term pramlintide trials IMPORTANCE Weight loss of 5 % to 10 % can improve type 2 diabetes and related comorbidities . Few safe , effective weight-management drugs are currently available . OBJECTIVE To investigate efficacy and safety of liraglutide vs placebo for weight management in adults with overweight or obesity and type 2 diabetes . DESIGN , SETTING , AND PARTICIPANTS Fifty-six-week r and omized ( 2:1:1 ) , double-blind , placebo- 
    Output:
    
Four types of interventions ( diet , surgery , pharmacological , and multi-component lifestyle interventions ) significantly reduced weight .
Weight loss was consistently associated with improvements in sexual and physical function across all intervention types , with diet and multi-component lifestyle interventions producing more substantial improvements than surgical or pharmacological interventions .
Findings for other PROs , such as HRQOL and depressive symptoms , were inconsistent across studies and intervention types .
The four weight loss interventions can be prescribed to engender weight loss in overweight and obese adults with T2D , with multi-component lifestyle interventions generating substantial improvements in physical and sexual function , perhaps due to the potency of exercise in improving PROs