Digital Dietary Intervention for Patients Receiving GLP-1 Receptor Agonist Therapy

Официальное название

Efficacy of a Digital Dietary Intervention (NutriSteppe Application) in Improving Metabolic Parameters in Adults With Type 2 Diabetes Mellitus, Obesity or Overweight With Comorbidities Who Are Receiving GLP-1 Receptor Agonist Therapy and Other Medications Prescribed Under Routine Clinical Protocols

Обзор

The goal of this clinical trial is to learn whether adding the NutriSteppe digital dietary intervention to routine medical care improves metabolic health in adults aged 21 to 65 years with type 2 diabetes mellitus, obesity, or overweight with related health conditions. Participants are already receiving or have been prescribed glucagon-like peptide-1 (GLP-1) receptor agonist therapy by their treating physicians outside the study. The main question is: Does the NutriSteppe digital dietary intervention improve glycated hemoglobin (HbA1c), a measure of average blood glucose, after 12 weeks compared with routine medical care alone? The study will also assess changes in fasting blood glucose, body weight, body mass index, waist circumference, cholesterol, triglycerides, blood pressure, diet quality, quality of life, dietary adherence, and safety. Researchers will randomly assign participants to one of two groups. The control group will continue routine medical care and receive general lifestyle advice. The intervention group will continue routine medical care and use the NutriSteppe application for 12 weeks to receive personalized dietary support. Participants in both groups will: * Attend study visits and complete the examinations, laboratory tests, and questionnaires specified in the study protocol. * Photograph everything they eat and drink. * Have their food photographs automatically analyzed using Tagam-AI, a system developed for this study. * Be able to view the results of the food photograph analysis. The photography and automated analysis procedures will be the same in both groups. Only participants in the intervention group will receive personalized dietary recommendations generated from these data through the NutriSteppe application.

Вмешательства

• Поведенческое NutriSteppe Digital Dietary Intervention
  The NutriSteppe mobile application provides personalized meal planning, a food diary, nutritional analysis, dietary goals, educational modules, culturally adapted recipes, progress monitoring, reminders, and dietary recommendations intended to support metabolic health and food tolerance during GLP-1 receptor agonist therapy. Participants use the application for 12 weeks, complete the food diary at least 5 days per week, record body weight weekly, review dietary suggestions, and complete weekly e

Первичные конечные точки

• Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 [Срок оценки: Baseline and Week 12]

Вторичные конечные точки (12)

• Change From Baseline in Fasting Plasma Glucose at Week 12 [Срок оценки: Baseline and Week 12]
• Proportion of Participants Achieving HbA1c Below 6.5% at Week 12 [Срок оценки: Week 12]
• Change From Baseline in Body Weight at Week 12 [Срок оценки: Baseline and Week 12]
• Percentage Change From Baseline in Body Weight at Week 12 [Срок оценки: Baseline and Week 12]
• Proportion of Participants Achieving at Least 5% Weight Loss at Week 12 [Срок оценки: Baseline and Week 12]
• Change From Baseline in Body Mass Index at Week 12 [Срок оценки: Baseline and Week 12]
• Change From Baseline in Waist Circumference at Week 12 [Срок оценки: Baseline and Week 12]
• Change From Baseline in LDL Cholesterol at Week 12 [Срок оценки: Baseline and Week 12]
• Change From Baseline in HDL Cholesterol at Week 12 [Срок оценки: Baseline and Week 12]
• Change From Baseline in Total Cholesterol at Week 12 [Срок оценки: Baseline and Week 12]
• Change From Baseline in Triglycerides at Week 12 [Срок оценки: Baseline and Week 12]
• Change From Baseline in LDL-C to HDL-C Ratio at Week 12 [Срок оценки: Baseline and Week 12]

Критерии участия

Критерии включения

• Age 21-65 years inclusive at the time of signing informed consent.
• Male or female.
• Overweight with at least one comorbidity, including diabetes mellitus; arterial hypertension of at least 130/85 mmHg or use of antihypertensive medication; dyslipidemia defined as triglycerides of at least 1.7 mmol/L, reduced HDL cholesterol below 1.0 mmol/L in men or below 1.3 mmol/L in women, or use of lipid-lowering medication; cardiovascular disease; respiratory or joint disease; non-alcoholic fatty liver disease; sleep disorders; or other comorbidities.
• For participants with overweight: body mass index of 25.0-29.9 kg/m² for the Caucasian population or 23.0-27.4 kg/m² for the Asian population, together with abdominal obesity defined as waist circumference of at least 94 cm in men and 80 cm in women of the European population, or at least 90 cm in men and 80 cm in women of the Asian population.
• Class I-III obesity where diet combined with physical activity has been ineffective, defined as weight loss of less than 5% over 3 months.
• Class I obesity: body mass index of 30.0-34.9 kg/m² for the Caucasian population or 27.5-32.4 kg/m² for the Asian population.
• Class II obesity: body mass index of 35.0-39.9 kg/m² for the Caucasian population or 32.5-37.4 kg/m² for the Asian population.
• Type 2 diabetes mellitus with HbA1c of at least 6.5% (48 mmol/mol), fasting glucose of at least 6.1 mmol/L in capillary whole blood or at least 7.0 mmol/L in venous plasma, glucose of at least 11.1 mmol/L two hours after an oral glucose tolerance test, or random glucose of at least 11.1 mmol/L.
• Body mass index of at least 25 kg/m² and no more than 40 kg/m² at screening.
• Already receiving, or prescribed, GLP-1 receptor agonist therapy with semaglutide by the treating physician independently of the study. The study does not prescribe or modify this therapy.
• Stable doses of medications for chronic conditions, including antihypertensive agents and statins, for at least 8 weeks before screening.
• Ownership of an iOS or Android smartphone with internet access and willingness to download and use the "NutriSteppe" application if assigned to the intervention group.
• Ability and willingness to provide written informed consent and comply with study procedures.
• Women of childbearing potential must use effective contraception throughout the study.

Критерии исключения

• Diagnosis of type 1 diabetes mellitus.
• History of diabetic ketoacidosis or hyperglycemic hyperosmolar state.
• Initiation of GLP-1 receptor agonist therapy less than 4 weeks before screening.
• Current insulin therapy.
• Personal or family history of medullary thyroid carcinoma.
• Personal history of multiple endocrine neoplasia type 2 (MEN2).
• History of acute or chronic pancreatitis.
• Active gallbladder disease or history of gallbladder disease within 6 months before screening.
• Severe gastrointestinal disease, including gastroparesis.
• Major cardiovascular event within 6 months before screening, including myocardial infarction, stroke, transient ischemic attack, unstable angina, coronary artery bypass grafting, or percutaneous coronary intervention.
• Uncontrolled arterial hypertension, defined as systolic blood pressure above 160 mmHg or diastolic blood pressure above 100 mmHg at screening.
• Chronic kidney disease with an estimated glomerular filtration rate below 30 mL/min/1.73 m² using the MDRD or CKD-EPI formula.
• Severe hepatic impairment classified as Child-Pugh class C, or ALT or AST greater than three times the upper limit of normal.
• Active malignancy or history of malignancy within 5 years, except successfully treated basal cell or squamous cell carcinoma of the skin.
• Established HIV infection, active hepatitis B defined as HBsAg positive with detectable HBV DNA, or hepatitis C virus infection.
• History of bariatric surgery or bariatric surgery planned during the study.
• Anorexia nervosa, bulimia nervosa, or binge eating disorder diagnosed or active within the past year.
• Pregnancy or breastfeeding.
• Planning pregnancy during the study.
• Woman of childbearing potential unwilling to use effective contraception.
• Use of weight-loss medication, including orlistat, phentermine, combinations with topiramate, naltrexone-bupropion, or other weight-loss medication within 3 months before screening.
• Use of systemic corticosteroids, excluding inhaled or topical corticosteroids, for more than 2 weeks within 3 months before screening.
• Use of antipsychotic medication associated with significant weight gain unless used at a stable dose for more than 6 months.
• Participation in another interventional clinical study within 30 days before screening.
• Known hypersensitivity to semaglutide or any excipient.
• No smartphone or unwillingness to use digital health technology.
• Severe mental disorder impairing the ability to provide informed consent or comply with the protocol.
• Active alcohol or drug dependence within the past year.
• Any condition that, in the investigator's opinion, may compromise participant safety or the integrity of the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Казахстан · 1 центр

• Kazakh Academy of Nutrition LLP — Almaty

Идентификаторы

NCT: NCT07728669 · NutriSteppe-MetS-2026-001 · AP26102783

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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