scholarly journals Outcomes of a Digitally Delivered Low-Carbohydrate Type 2 Diabetes Self-Management Program: 1-Year Results of a Single-Arm Longitudinal Study (Preprint)

2017 ◽  
Author(s):  
Laura R Saslow ◽  
Charlotte Summers ◽  
James E Aikens ◽  
David J Unwin

BACKGROUND Type 2 diabetes mellitus has serious health consequences, including blindness, amputation, stroke, and dementia, and its annual global costs are more than US $800 billion. Although typically considered a progressive, nonreversible disease, some researchers and clinicians now argue that type 2 diabetes may be effectively treated with a carbohydrate-reduced diet. OBJECTIVE Our objective was to evaluate the 1-year outcomes of the digitally delivered Low-Carb Program, a nutritionally focused, 10-session educational intervention for glycemic control and weight loss for adults with type 2 diabetes. The program reinforces carbohydrate restriction using behavioral techniques including goal setting, peer support, and behavioral self-monitoring. METHODS The study used a quasi-experimental research design comprised of an open-label, single-arm, pre-post intervention using a sample of convenience. From adults with type 2 diabetes who had joined the program and had a complete baseline dataset, we randomly selected participants to be followed for 1 year (N=1000; mean age 56.1, SD 15.7 years; 59.30% (593/1000) women; mean glycated hemoglobin A1c (HbA1c) 7.8%, SD 2.1%; mean body weight 89.6 kg, SD 23.1 kg; taking mean 1.2, SD 1.01 diabetes medications). RESULTS Of the 1000 study participants, 708 (70.80%) individuals reported outcomes at 12 months, 672 (67.20%) completed at least 40% of the lessons, and 528 (52.80%) completed all lessons of the program. Of the 743 participants with a starting HbA1c at or above the type 2 diabetes threshold of 6.5%, 195 (26.2%) reduced their HbA1c to below the threshold while taking no glucose-lowering medications or just metformin. Of the participants who were taking at least one hypoglycemic medication at baseline, 40.4% (289/714) reduced one or more of these medications. Almost half (46.40%, 464/1000) of all participants lost at least 5% of their body weight. Overall, glycemic control and weight loss improved, especially for participants who completed all 10 modules of the program. For example, participants with elevated baseline HbA1c (≥7.5%) who engaged with all 10 weekly modules reduced their HbA1c from 9.2% to 7.1% (P<.001) and lost an average of 6.9% of their body weight (P<.001). CONCLUSIONS Especially for participants who fully engage, an online program that teaches a carbohydrate-reduced diet to adults with type 2 diabetes can be effective for glycemic control, weight loss, and reducing hypoglycemic medications.

2021 ◽  
Author(s):  
Rajaa Nahra ◽  
Tao Wang ◽  
Kishore M. Gadde ◽  
Jan Oscarsson ◽  
Michael Stumvoll ◽  
...  

<a><b>Objective: </b></a>Cotadutide, a <a>dual GLP-1 and glucagon receptor agonist</a>, is under development for nonalcoholic steatohepatitis (NASH) and type 2 diabetes. The effects of cotadutide on hepatic and metabolic parameters were evaluated in participants with overweight/obesity and type 2 diabetes. <p><b>Research Design and Methods:</b> In this phase 2b study, 834 adults with BMI ≥25kg/m<sup>2</sup> and type 2 diabetes inadequately controlled with metformin (glycated hemoglobin A1c [HbA1c] of 7.0%─10.5% [53─91 mmol/mol]) were randomized to double-blind cotadutide 100µg (n=100), 200µg (n=256), or 300µg (n=256), placebo (n=110), or open-label liraglutide 1.8mg (n=110), all administered subcutaneously (NCT03235050). Coprimary endpoints were changes in HbA1c and body weight at week 14.<b> </b>The originally randomized interventions were continued to week 54.<b> </b>Liver damage biomarkers and liver fibrosis algorithms were assessed.</p> <p><b>Results</b>: Cotadutide significantly decreased HbA1c and body weight at weeks 14 and 54 versus placebo (all <i>P</i><0.001). Improvements in lipid profile, aspartate aminotransferase and alanine aminotransferase levels, <a>PRO-C3 level, fibrosis-4 index</a>, and <a>nonalcoholic fatty liver disease fibrosis score</a> were observed with cotadutide 300µg versus placebo, but not with liraglutide. Weight loss with cotadutide 200µg was similar to liraglutide 1.8mg, and greater with cotadutide 300µg versus liraglutide 1.8mg. <a>The most common adverse events with cotadutide (nausea, 35%; vomiting, 17%) decreased over time. </a></p> <p><b>Conclusions: </b>Cotadutide treatment for 54 weeks improved glycemic control and weight loss in participants with overweight/obesity and type 2 diabetes. Ad hoc analyses demonstrated improvements in hepatic parameters and support further evaluation of cotadutide in NASH. </p>


Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Soohyun Nam ◽  
Soohyun Nam ◽  
Devon A Dobrosielski ◽  
Kerry J Stewart

Background: Though a high amount of visceral fat is associated with insulin resistance, which can lead to type 2 diabetes (T2D) and cardiovascular diseases (CVDs), less is known about whether lifestyle modification (weight loss diet and exercise) induced changes in visceral fat are associated with improvements in glycemia. Methods: We randomized 77 individuals aged 35-65 years with T2D or pre-diabetes to 6-months of weight loss diet (D); or D combined with supervised moderate-intensity exercise training (D+E). Study measures were total abdominal, visceral and subcutaneous fat volumes by magnetic resonance imaging, aerobic fitness expressed as VO 2 peak during treadmill testing, body mass index (BMI), and HbA1c levels from blood samples. Results: Of 77 subjects (mean age, 54.8±7.8 years; mean BMI, 34.5 ± 4.7 kg/m 2 , women, 77.9%; Whites-65%, Blacks-34%, Asians-1%), n=37 had T2D and n=40 had pre-diabetes. At 6 months, both D and D+E groups improved from baseline (p<0.05 for all) but did not differ in their changes for body weight (D: -6.04 ± 4.54 kg; D+E: -6.68 ± 4.48 kg, p= 0.61 for the group differences in change), abdominal total fat (D: -101.93 ± 68.67 cm 2 ; D+E:-104.16 ± 72.37 cm 2 , p= 0.92), visceral fat (D:-25.53 ± 39.44 cm 2 ; D+E:,-23.24 ± 35.62 cm 2 , p=0.85), HbA1c (D:0.04 ± 0.46%; D+E:0.03 ± 0.63%, p=0.96), and VO 2 peak (D: 2.26 ± 3.92 ml/kg/min ; D+E:3.71 ± 2.65 ml/kg/min, p=0.11). In a multivariate analysis, adjusting for baseline visceral fat, T2D status, body weight loss and increases in aerobic fitness, a reduction in HbA1c (β=-0.49, p =0.007) was associated with a reduction in visceral fat (R 2 =0.34, p=0.02). Conclusion: The key finding was that diet or diet plus exercise-mediated reductions in visceral fat was associated with reduced HbA1c among individuals with T2D or pre-diabetes. These data contribute to growing body of evidence of the benefits of reducing abdominal obesity, in this case, resulting in better glycemic control in T2D and pre-diabetes.


2019 ◽  
Vol 7 (1) ◽  
pp. e000659 ◽  
Author(s):  
Shaheen Tomah ◽  
Noor Mahmoud ◽  
Adham Mottalib ◽  
David M Pober ◽  
Mhd Wael Tasabehji ◽  
...  

ObjectiveWe evaluated the relationship between frequency of self-monitoring of blood glucose (SMBG) and body weight, A1C, and cardiovascular risk factors in patients with type 2 diabetes (T2D) and obesity enrolled in a 12-week intensive multidisciplinary weight management (IMWM) program.Research design and methodsWe conducted a retrospective analysis of 42 patients who electronically uploaded their SMBG data over 12 weeks of an IMWM program and divided them into tertiles based on their average frequency of SMBG per day. Mean (range) SMBG frequencies were 2.3 (1.1–2.9) times/day, 3.4 (3–3.9) times/day, and 5 (4–7.7) times/day in the lowest, middle, and highest tertiles, respectively. Anthropometric and metabolic parameters were measured at baseline and after 12 weeks of intervention.ResultsParticipants in the highest tertile achieved a median change (IQR) in body weight of −10.4 kg (−7.6 to −14.4 kg) compared with −8.3 kg (−5.2 to −12.2 kg), and −6.9 kg (−4.2 to −8.9 kg) in the middle and lowest tertiles, respectively (p=0.018 for trend). Participants in the highest tertile had a median change (IQR) in A1C of −1.25% (−0.6 to −3.1%) compared with −0.8% (−0.3% to −2%) and −0.5% (−0.2% to −1.2%) in the middle and lowest tertiles, respectively (p=0.048 for trend). The association between change in body weight and SMBG frequency remained significant after adjusting for age, sex, baseline body mass index, diabetes duration, and use of insulin therapy.ConclusionsIncreased frequency of SMBG during IMWM is associated with significantly better weight loss and improvement of A1C in patients with T2D and obesity. These findings may suggest future clinical recommendations aimed at increasing SMBG frequency to achieve the most favorable outcomes.


2012 ◽  
Vol 15 (7) ◽  
pp. A494
Author(s):  
C. Mcadam-marx ◽  
B.K. Bellows ◽  
G.D. Wygant ◽  
J. Mukherjee ◽  
S. Unni ◽  
...  

2021 ◽  
Author(s):  
Rajaa Nahra ◽  
Tao Wang ◽  
Kishore M. Gadde ◽  
Jan Oscarsson ◽  
Michael Stumvoll ◽  
...  

<a><b>Objective: </b></a>Cotadutide, a <a>dual GLP-1 and glucagon receptor agonist</a>, is under development for nonalcoholic steatohepatitis (NASH) and type 2 diabetes. The effects of cotadutide on hepatic and metabolic parameters were evaluated in participants with overweight/obesity and type 2 diabetes. <p><b>Research Design and Methods:</b> In this phase 2b study, 834 adults with BMI ≥25kg/m<sup>2</sup> and type 2 diabetes inadequately controlled with metformin (glycated hemoglobin A1c [HbA1c] of 7.0%─10.5% [53─91 mmol/mol]) were randomized to double-blind cotadutide 100µg (n=100), 200µg (n=256), or 300µg (n=256), placebo (n=110), or open-label liraglutide 1.8mg (n=110), all administered subcutaneously (NCT03235050). Coprimary endpoints were changes in HbA1c and body weight at week 14.<b> </b>The originally randomized interventions were continued to week 54.<b> </b>Liver damage biomarkers and liver fibrosis algorithms were assessed.</p> <p><b>Results</b>: Cotadutide significantly decreased HbA1c and body weight at weeks 14 and 54 versus placebo (all <i>P</i><0.001). Improvements in lipid profile, aspartate aminotransferase and alanine aminotransferase levels, <a>PRO-C3 level, fibrosis-4 index</a>, and <a>nonalcoholic fatty liver disease fibrosis score</a> were observed with cotadutide 300µg versus placebo, but not with liraglutide. Weight loss with cotadutide 200µg was similar to liraglutide 1.8mg, and greater with cotadutide 300µg versus liraglutide 1.8mg. <a>The most common adverse events with cotadutide (nausea, 35%; vomiting, 17%) decreased over time. </a></p> <p><b>Conclusions: </b>Cotadutide treatment for 54 weeks improved glycemic control and weight loss in participants with overweight/obesity and type 2 diabetes. Ad hoc analyses demonstrated improvements in hepatic parameters and support further evaluation of cotadutide in NASH. </p>


2020 ◽  
Author(s):  
Charlotte Summers ◽  
Simon Tobin ◽  
David Unwin

BACKGROUND Type 2 diabetes mellitus has serious health consequences, including blindness, amputation, and stroke. There is increasing evidence that type 2 diabetes may be effectively treated with a carbohydrate-reduced diet. Digital apps are increasingly used as an adjunct to traditional health care provisions to support behaviour change and remote self-management of long-term health conditions. OBJECTIVE Our objective was to evaluate the real-world 12-month outcomes of patients prescribed the Low Carb Program (LCP) digital health at a primary care NHS site, Norwood Surgery in Southport, United Kingdom. The Low Carb Program is a nutritionally focused, digitally delivered behaviour change intervention for glycemic control and weight loss for adults with prediabetes and type 2 diabetes. METHODS We evaluated the real-world, self-reported outcomes of patients referred to the Low Carb Program by doctors at an NHS GP surgery in Southport, United Kingdom. All of the NHS patients referred to the program were diagnosed with Type 2 diabetes mellitus (T2DM) or prediabetes and given the program at no cost (N=45; mean age 54.8, SD 13.2 years; 42% (19/45) women; mean glycated hemoglobin A1c (HbA1c) 56.7 mmol/mol (range 42.1mmol/mol - 96.7mmol/mol); mean body weight 89.4 kg (SD 13.8 kg). RESULTS Of the 100 people offered the program 45 participants enrolled, all of them (100%) activated their accounts and 37 (82.2%) individuals self-reported outcomes at 12-months. Of those who enrolled 45 (100%) patients completed at least 40% of the lessons, 32 (71.1%) individuals completed >9 out of 12 core lessons of the program. Glycemic control and weight loss improved, particularly for participants who completed >9 of the 12 core lessons in the program over 12-months; mean HbA1c went from 58.8 mmol/mol at baseline to 54.0 mmol/mol (4.78 mmol/mol, SD 4.60), t(31)=5.87, p<0.001) and reported an average 4.17% total body weight reduction with an average reduction of 3.85kg (SD 2.35), t(31)=9.27, p<0.001) at the 12-month follow up point. CONCLUSIONS Though the data presented here has several limitations, the use of a digital app prescribed to adults with T2DM or prediabetes in a primary care setting supporting a transition to a low carbohydrate diet appears to show significant improvements in glycaemic control and weight loss. Further research to understand more about factors affecting engagement and further positive health implications would be valuable.


2012 ◽  
Vol 15 (2) ◽  
pp. 17-21 ◽  
Author(s):  
Leonid Grigor'evich Strongin ◽  
Il'ya Grigor'evich Pochinka ◽  
Maria Sergeevna Konysheva ◽  
Elena Pavlovna Morozova

Aims. To assess contribution of therapeutic training, blood glucose self-monitoring and general improvement of glycemic control on development ofchronic heart failure (CHF) in patients with type 2 diabetes mellitus (T2DM). Materials and methods. We conducted a prospective, open-label, non-controlled before/after study. 80 patients with T2DM took part in this trialafter initial hospitalization for decompensation of both CHF and diabetes (НbА1с>=8.0%). Therapeutic training as well as provision of tools and consumablesfor self-monitoring was arranged for all patients. Therapeutic goal was set to lowering НbА1с for?1% by the end of 12 months of follow-up. Results. We observed lowering of НbА1с values from 9.3% [8,4-10,6] to 8.8% [7,6-10,0] (р


2021 ◽  
Vol 1 (1) ◽  
pp. 12-15
Author(s):  
Mohammed Ashfaqul Ghani ◽  
◽  
Christopher Uy ◽  
Aye Thet Hlyar Oo ◽  

Introduction: Diabetes mellitus is increasing rapidly worldwide, and treatment comes with many challenges. It is estimated that in 2030, approximately 500 million people will live with diabetes across the world—most of which will be type 2 diabetes mellitus (T2DM). Obesity often coincides with T2DM and has been linked to increased insulin resistance, high blood pressure, and high blood lipids. Thus, pharmacological management should be aimed at promoting weight loss or at very least be weight neutral. In many cases the risks of hypoglycaemia and weight gain may delay titration of diabetic agents to HbA1C targets. Both insulin and sulfonylureas are proven medications which are beneficial for tight glycemic control but with an increased risk of weight gain and hypoglycaemia. Newer agents under the drug class glucagon-like peptide receptor antagonists (GLP-1RA) are increasingly being used. Various randomized clinical trials support that obese T2DM patients treated with GLP-1RA lead to better glycaemic control, weight reduction and reduced risk of hypoglycaemia. Case Summary: A 56-year-old female was diagnosed with T2DM in 2003 and had been regularly followed up in diabetes clinic since 2014. During the initial clinic review she had a body weight of 114.9 kg (BMI 40.7), fasting blood glucose was 8 - 9, 2-hour CBG 11-13 and HbA1c of 87. At that time, she was taking insulin glargine (Lantus) 36 units once daily, gliclazide 40 mg in the morning / 120 mg in the evening, metformin slow release 2 g in the evening, and simvastatin 20 mg at bedtime. After discussion with her she was started on the GLP-1RA liraglutide subcutaneously. She had no diabetic related complication. She continued liraglutide since then. Her HbA1c started to improve and also noticed in change in body weight which had gradually decreased from 114.9 to 109 kg. Her liraglutide was held at the latter end of 2018 as her glucose control and weight had been maintained. It was noticed that after stopping liraglutide her blood glucose and weight started to go up again even though her other medications remained same. Her case was discussed at Diabetes MDT and liraglutide1.8mg restarted in September 2019 and since then she able to lose around 5% of her body weight and HBA1C also started to drop. It is noticed that since the starting of her liraglutide her HBA1C level and weight fall by around 1% and 4% respectively. In late 2018 once she stopped liraglutide her HbA1C and weight started to rise again. In 2019 liraglutide was restarted and she managed to reduce body weight by 5kg and HbA1C by 2%. During the whole time period she maintained lifestyle intervention. Discussion: Excessive fat accumulation with potential impairing effects on health know as overweight and obesity, is a major risk factor for type 2 diabetes mellitus. Most T2DM people around 80-90% fall in mild to moderate obesity or overweight need either behaviour or medication-based weight loss programme. In these patients losing as little as 5% of body weight positively affect their cardiovascular mortality and glycemic control. There is no need to mention that losing body weight and maintaining it is a challenge for the majority of diabetic patients and it is especially true for those are on oral hypoglycaemic agents such as insulin, sulfonylurea and thiazolidinediones and insulin. In that case GLP-! Receptor agonists (GLP-1 Ras) is exceptional and it is proven benefit in reducing weight in T2DM obese patients. Liraglutide is first approved in 2010 as an adjunct therapy to diet and exercise for management of type 2 diabetes. Liraglutide is a derivative of GLP-1, a polypeptide incretin hormone secreted by the L-cell of the gastrointestinal tract. It stimulates glucose dependent insulin secretion causing a decrease in plasma glucagon concentrations, delayed gastric emptying, suppress appetite and increased heart rate. It is believed that the weight lowering effect of GLP-1RA is due to appetite suppression and delayed gastric emptying. After liraglutide administration peak absorption occur at 11 hours and its absolute bioavailability is 55%. Its half-life in 13 hours, allowing it once daily administration. It eliminates through liver and kidneys and does not interfere with cytochrome p450 system. Most common side effects are nausea, hypoglycaemia, diarrhoea, constipation, abdominal pain and increased serum lipase. Gastrointestinal intolerance is the most common reason for drug discontinuation in patients. There is also an increased correlation with acute pancreatitis, serious hypoglycaemic episodes, tachycardia, and suicidal behaviour. Liraglutide is contraindicated in pregnancy and should be avoided in nursing mothers, children, and coincident use with other GLP-1 agonists. Five large scale randomized multicenter phase III trials have been conducted to evaluate the efficacy of liraglutide as a weight loss agent. Four of these are part of the Satiety and Clinical Adiposity – Liraglutide evidence in non‐diabetic and diabetic individuals (SCALE) program. During these trails, all participants were encouraged to continue their lifestyle modification. The result of the trail was satisfactory. It was found that mean weight loss was between 6% to 4.7% in comparison to placebo group (2%). A dose dependent weight loss was first observed in LEAD Trials and subsequently in SCALE programme it is confirmed. In a study in Chinese population liraglutide treatment help T2DM patient in weight reduction after 24 weeks of treatment. In long term weight reduction, the 5-year treatment with liraglutide reduce HBA1c level by almost 1%. In various study it confirmed that liraglutide has greater impact on T2DM female gender. In SCALE study it showed that 50% difference in body weight loss between man and women could be due to higher exposure to liraglutide to women. Although exposure was equal in healthy male and female subject. Reference: 1. Randomized control trials for GLP-1Ra 2. Liraglutide for weight management: A critical review of the evidence 3. A review of efficacy and safety data regarding the use of liraglutide, a once-daily human glucagon-like peptide 1 analogue, in the treatment of type 2 diabetes mellitus. 4. Long-Term Effectiveness of Liraglutide for Weight Management and Glycemic Control in Type 2 Diabetes


2021 ◽  
Vol 12 ◽  
Author(s):  
Ping Zhong ◽  
Hai Zeng ◽  
Miaochun Huang ◽  
Guoxin He ◽  
Zhixia Chen

Background: This meta-analysis aimed to combine the data available from clinical trials to assess the effects of subcutaneous and oral semaglutide administration on glycemic control, weight management, and safety outcomes in patients with type 2 diabetes (T2D).Methods: We systematically searched for phase 3 randomized controlled trials (RCTs) that compared semaglutide with placebo or other anti-diabetic drugs in T2D patients. The primary outcome was the change from baseline in glycated hemoglobin (HbA1c) levels. Secondary efficacy endpoints included the change from baseline in body weight, achievement of HbA1c targets, and clinically significant weight loss. Key safety outcomes were also assessed.Results: In this meta-analysis, 24 trials with a total of 22185 patients were included. Subcutaneous semaglutide administration reduced HbA1c levels (weighted mean difference [WMD]: −1.14% and −1.37%, for 0.5 mg and 1 mg, respectively) and body weight (WMD: −2.73 kg and −4.09 kg, for 0.5 mg and 1 mg, respectively) when compared with placebo; its efficacy was also superior to other anti-diabetic drugs in reducing HbA1c levels (WMD: −0.71% and −0.86%, for 0.5 mg and 1 mg, respectively) and body weight (WMD: −2.65 kg and −3.78 kg, for 0.5 mg and 1 mg, respectively). Oral semaglutide administration was superior to placebo in decreasing HbA1c levels (WMD: −0.96% and −1.02%, for 7 mg and 14 mg, respectively). Moreover, oral administration of 14 mg of semaglutide also showed a significant reduction in HbA1c levels (WMD: −0.36%) compared with other anti-diabetic drugs. Furthermore, oral semaglutide administration resulted in substantial weight loss compared with other anti-diabetic drugs (WMD: −1.53 kg and −1.73 kg, for 7 mg and 14 mg, respectively). Notably, subcutaneous and oral semaglutide administration also resulted in higher numbers of patients achieving the targets of HbA1c levels and weight loss than placebo and other anti-diabetic drugs. Overall, we noted no clear evidence of detrimental effects on safety endpoints due to semaglutide treatment, except for some gastrointestinal adverse events.Conclusion: Both subcutaneous and oral semaglutide administration could enable the achievement of sufficient glycemic control and weight management without increasing the risk of hypoglycemia, which were effective and safe for the treatment of T2D.


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