Type 2 Diabetes Mellitus (T2DM)NutriSteppeNCT07728669
Digital Dietary Intervention for Patients Receiving GLP-1 Receptor Agonist Therapy
A study testing NutriSteppe Digital Dietary Intervention in people with Type 2 Diabetes Mellitus (T2DM) and Obesity (Disorder), run by Kazakh Academy of Nutrition at 1 site in Kazakhstan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Obesity (Disorder), Overweight
- What is being tested?
- NutriSteppe Digital Dietary Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteKazakhstan
- Study dates
- 20 Jul 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
Show all 29Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kazakhstan1 site, 1 recruiting
- Recruiting
Kazakh Academy of Nutrition LLP
Almaty, 050008
Almaz Sharman, +77771114202, Almaz@Sharman.pro
About this study
Official title: 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
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:
Read more
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.
- Being tested
- NutriSteppe Digital Dietary Intervention
- Keywords
- NutriSteppe, Digital Dietary Intervention, Personalized Nutrition, GLP-1 Receptor Agonist, Semaglutide, Glycated Hemoglobin, HbA1c
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Overweight, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutriSteppe Digital Dietary InterventionBehavioural
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 educational modules.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants receive routine medical care, including GLP-1 receptor agonist therapy and other medications prescribed by their treating physician outside the study, together with general lifestyle advice. Participants do not have access to the NutriSteppe personalized dietary intervention during the 12-week study period. Participants photograph all eating occasions for dietary intake measurement. The photographs are analyzed automatically using Tagam-AI, and the analysis results are displayed to participants. The photographic recording, automated analysis, and display of results are identical in both study groups. Participants in the control group do not receive personalized dietary recommendations generated from these data. |
| NutriSteppe Intervention Group | Experimental | Participants receive routine medical care, including GLP-1 receptor agonist therapy and other medications prescribed by their treating physician outside the study, together with a 12-week personalized digital dietary intervention delivered through the NutriSteppe application.
Participants photograph all eating occasions for dietary intake measurement. The photographs are analyzed automatically using Tagam-AI, and the analysis results are displayed to participants. The photographic recording, automated analysis, and display of results are identical in both study groups. Only participants in this group receive personalized dietary recommendations generated from these data through the NutriSteppe application. Receives: Behavioral: NutriSteppe Digital Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12
HbA1c will be measured as a percentage at baseline and at week 12. Change will be calculated as the week 12 value minus the baseline value. A negative change indicates a reduction in HbA1c.
Measured: Baseline and Week 12
Secondary outcomes (27)
Change From Baseline in Fasting Plasma Glucose at Week 12
Fasting plasma glucose will be measured in mmol/L at baseline and at week 12. Change will be calculated as the week 12 value minus the baseline value. A negative change indicates a reduction in fasting plasma glucose.
Measured: Baseline and Week 12
Proportion of Participants Achieving HbA1c Below 6.5% at Week 12
The proportion of participants with glycated hemoglobin (HbA1c) below 6.5% at week 12 will be calculated as the number of participants meeting this threshold divided by the number of participants assessed.
Measured: Week 12
Change From Baseline in Body Weight at Week 12
Body weight will be measured in kilograms at baseline and at week 12. Change will be calculated as the week 12 value minus the baseline value. A negative change indicates weight loss.
Measured: Baseline and Week 12
Percentage Change From Baseline in Body Weight at Week 12
Percentage change in body weight will be calculated as the difference between body weight at week 12 and baseline body weight, divided by baseline body weight and multiplied by 100. A negative value indicates weight loss.
Measured: Baseline and Week 12
Proportion of Participants Achieving at Least 5% Weight Loss at Week 12
The proportion of participants whose body weight decreases by at least 5% from baseline to week 12 will be calculated.
Measured: Baseline and Week 12
Change From Baseline in Body Mass Index at Week 12
Body mass index will be calculated in kg/m² at baseline and at week 12. Change will be calculated as the week 12 value minus the baseline value. A negative change indicates a reduction in body mass index.
Measured: Baseline and Week 12
Change From Baseline in Waist Circumference at Week 12
Waist circumference will be measured in centimeters at baseline and at week 12. Change will be calculated as the week 12 value minus the baseline value. A negative change indicates a reduction in waist circumference.
Measured: Baseline and Week 12
Change From Baseline in LDL Cholesterol at Week 12
Low-density lipoprotein cholesterol will be measured in mmol/L at baseline and at week 12. Change will be calculated as the week 12 value minus the baseline value.
Measured: Baseline and Week 12
Change From Baseline in HDL Cholesterol at Week 12
High-density lipoprotein cholesterol will be measured in mmol/L at baseline and at week 12. Change will be calculated as the week 12 value minus the baseline value.
Measured: Baseline and Week 12
Change From Baseline in Total Cholesterol at Week 12
Total cholesterol will be measured in mmol/L at baseline and at week 12. Change will be calculated as the week 12 value minus the baseline value.
Measured: Baseline and Week 12
Change From Baseline in Triglycerides at Week 12
Triglycerides will be measured in mmol/L at baseline and at week 12. Change will be calculated as the week 12 value minus the baseline value.
Measured: Baseline and Week 12
Change From Baseline in LDL-C to HDL-C Ratio at Week 12
The ratio of low-density lipoprotein cholesterol to high-density lipoprotein cholesterol will be calculated at baseline and at week 12. Change will be calculated as the week 12 ratio minus the baseline ratio.
Measured: Baseline and Week 12
Proportion of Participants Achieving LDL-C Below 2.6 mmol/L at Week 12
The proportion of participants with low-density lipoprotein cholesterol below 2.6 mmol/L at week 12 will be calculated.
Measured: Week 12
Change From Baseline in Systolic Blood Pressure at Week 12
Systolic blood pressure will be measured in mmHg at baseline and at week 12. Change will be calculated as the week 12 value minus the baseline value.
Measured: Baseline and Week 12
Change From Baseline in Diastolic Blood Pressure at Week 12
Diastolic blood pressure will be measured in mmHg at baseline and at week 12. Change will be calculated as the week 12 value minus the baseline value.
Measured: Baseline and Week 12
Proportion of Participants Achieving Blood Pressure Below 130/80 mmHg at Week 12
The proportion of participants with systolic blood pressure below 130 mmHg and diastolic blood pressure below 80 mmHg at week 12 will be calculated.
Measured: Week 12
Number of Participants With Adverse Events by Severity
Adverse events will be recorded and graded by severity according to the Common Terminology Criteria for Adverse Events version 5.0. Events will be classified as grade 1 mild, grade 2 moderate, grade 3 severe, grade 4 life-threatening, or grade 5 fatal.
Measured: From informed consent through 30 days after the Week 12 visit
Number of Participants With Serious Adverse Events
The number of participants experiencing at least one serious adverse event will be recorded. Serious adverse events include death, a life-threatening event, hospitalization or prolonged hospitalization, significant disability, congenital anomaly, or another medically important event.
Measured: From informed consent through 30 days after the Week 12 visit
Change From Baseline in Vital Signs Through Week 12
Changes in vital signs, including blood pressure and heart rate, will be assessed during study visits.
Measured: Baseline through Week 12
Change From Baseline in Safety Laboratory Parameters at Week 12
Changes in safety laboratory parameters will be assessed from baseline to week 12. Evaluations include liver function tests and renal function tests specified in the study protocol.
Measured: Baseline and Week 12
Proportion of Participants Who Discontinue the Study Early
The proportion of participants who discontinue study participation before completing the week 12 visit will be calculated.
Measured: Baseline through Week 12
Change From Baseline in the Adapted 14-Item Mediterranean Diet Adherence Screener Score at Week 12
Diet quality will be assessed using the adapted 14-item Mediterranean Diet Adherence Screener (MEDAS). Each item is scored as 0 or 1, and the item scores are summed to produce a total score ranging from 0 to 14. Higher scores indicate greater adherence to healthy dietary recommendations. Scores from 0 to 5 indicate low adherence, scores from 6 to 9 indicate moderate adherence, and scores from 10 to 14 indicate high adherence. These categories are used only for descriptive reporting. The primary analysis uses the total score as a continuous variable. Change will be calculated as the week 12 score minus the baseline score.
The adapted version differs from the original PREDIMED MEDAS. It assesses unsweetened green or herbal tea instead of wine and does not require at least one vegetable serving to be consumed raw. The adapted version has not been psychometrically validated.
Measured: Baseline and Week 12
Change From Baseline in the 12-Item Short Form Health Survey Physical Component Summary Score at Week 12
Physical health-related quality of life will be assessed using the Physical Component Summary (PCS) score of the 12-Item Short Form Health Survey (SF-12). The PCS score is calculated using the official licensed QualityMetric/Optum Insight scoring algorithm and is reported on a norm-based scale ranging from 0 to 100. Higher scores indicate better physical health-related quality of life. Change will be calculated as the week 12 score minus the baseline score.
Measured: Baseline and Week 12
Change From Baseline in the 12-Item Short Form Health Survey Mental Component Summary Score at Week 12
Mental health-related quality of life will be assessed using the Mental Component Summary (MCS) score of the 12-Item Short Form Health Survey (SF-12). The MCS score is calculated using the official licensed QualityMetric/Optum Insight scoring algorithm and is reported on a norm-based scale ranging from 0 to 100. Higher scores indicate better mental health-related quality of life. Change will be calculated as the week 12 score minus the baseline score.
Measured: Baseline and Week 12
Mean Item Score on the Study-Specific Dietary Adherence Self-Assessment Questionnaire
Dietary adherence in the intervention group will be assessed using the study-specific Dietary Adherence Self-Assessment Questionnaire developed for this study. The instrument contains 9 positively worded items. Each item is scored from 1 (never) to 5 (always), with no reverse scoring. The primary measure is the mean item score, ranging from 1.0 to 5.0. Higher scores indicate better self-reported dietary adherence.
If 1 or 2 items are missing, the mean is calculated using the answered items. If 3 or more items are missing, the score is considered invalid and recorded as missing. The instrument has not been validated and has no validated cut-off values.
Measured: Weeks 4, 8, and 12
Overall Self-Rated Dietary Adherence in the Intervention Group
Overall dietary adherence will be self-rated using a study-specific numerical scale ranging from 0 to 100. Higher scores indicate better self-reported dietary adherence. This score is analyzed separately and is not combined with the mean score from the 9 questionnaire items. The scale has not been validated and has no validated cut-off values.
Measured: Weeks 4, 8, and 12
Usability of the NutriSteppe Application Assessed Using the System Usability Scale
Application usability will be assessed using the 10-item System Usability Scale (SUS). The total score ranges from 0 to 100, with higher scores indicating better perceived usability of the "NutriSteppe" application.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start20 Jul 2026
- Primary completionNov 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kazakh Academy of Nutrition
- Sponsor type
- University, hospital or other
- Collaborators
- Science Committee of the Ministry of Science and Higher Education of the Republic of Kazakhstan
- Responsible party
- Sponsor
- Investigators
- Almaz Sharman, MD, PhD, Principal investigator, Kazakh Academy of Nutrition LLP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728669
- Sponsor's protocol ID
- NutriSteppe-MetS-2026-001
- Other IDs
- AP26102783
- Acronym
- NutriSteppe
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data may be shared with qualified researchers upon reasonable request after publication of the primary study results.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07728669
- Acronym / sponsor ID
- NutriSteppe / NutriSteppe-MetS-2026-001
- Keywords
- NutriSteppe, Digital Dietary Intervention, Personalized Nutrition, GLP-1 Receptor Agonist, Semaglutide, Glycated Hemoglobin, HbA1c
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kazakh Academy of NutritionUniversity, hospital or other
- Collaborators
- Science Committee of the Ministry of Science and Higher Education of the Republic of Kazakhstan
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants receive routine medical care, including GLP-1 receptor agonist therapy and other medications prescribed by their treating physician outside the study, together with general lifestyle advice. Participants do not have access to the NutriSteppe personalized dietary intervention during the 12-week study period. Participants photograph all eating occasions for dietary intake measurement. The photographs are analyzed automatically using Tagam-AI, and the analysis results are displayed to participants. The photographic recording, automated analysis, and display of results are identical in both study groups. Participants in the control group do not receive personalized dietary recommendations generated from these data. |
| NutriSteppe Intervention Group | Experimental | Behavioral: NutriSteppe Digital Dietary InterventionParticipants receive routine medical care, including GLP-1 receptor agonist therapy and other medications prescribed by their treating physician outside the study, together with a 12-week personalized digital dietary intervention delivered through the NutriSteppe application. Participants photograph all eating occasions for dietary intake measurement. The photographs are analyzed automatically using Tagam-AI, and the analysis results are displayed to participants. The photographic recording, automated analysis, and display of results are identical in both study groups. Only participants in this group receive personalized dietary recommendations generated from these data through the NutriSteppe application. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NutriSteppe Digital Dietary InterventionThe 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 educational modules. | Behavioural | NutriSteppe Intervention Group |
Primary outcome
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12
Time frame: Baseline and Week 12
HbA1c will be measured as a percentage at baseline and at week 12. Change will be calculated as the week 12 value minus the baseline value. A negative change indicates a reduction in HbA1c.
27 secondary outcomes
Change From Baseline in Fasting Plasma Glucose at Week 12
Time frame: Baseline and Week 12
Proportion of Participants Achieving HbA1c Below 6.5% at Week 12
Time frame: Week 12
Change From Baseline in Body Weight at Week 12
Time frame: Baseline and Week 12
Percentage Change From Baseline in Body Weight at Week 12
Time frame: Baseline and Week 12
Proportion of Participants Achieving at Least 5% Weight Loss at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Body Mass Index at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Waist Circumference at Week 12
Time frame: Baseline and Week 12
Change From Baseline in LDL Cholesterol at Week 12
Time frame: Baseline and Week 12
Change From Baseline in HDL Cholesterol at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Total Cholesterol at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Triglycerides at Week 12
Time frame: Baseline and Week 12
Change From Baseline in LDL-C to HDL-C Ratio at Week 12
Time frame: Baseline and Week 12
Proportion of Participants Achieving LDL-C Below 2.6 mmol/L at Week 12
Time frame: Week 12
Change From Baseline in Systolic Blood Pressure at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Diastolic Blood Pressure at Week 12
Time frame: Baseline and Week 12
Proportion of Participants Achieving Blood Pressure Below 130/80 mmHg at Week 12
Time frame: Week 12
Number of Participants With Adverse Events by Severity
Time frame: From informed consent through 30 days after the Week 12 visit
Number of Participants With Serious Adverse Events
Time frame: From informed consent through 30 days after the Week 12 visit
Change From Baseline in Vital Signs Through Week 12
Time frame: Baseline through Week 12
Change From Baseline in Safety Laboratory Parameters at Week 12
Time frame: Baseline and Week 12
Proportion of Participants Who Discontinue the Study Early
Time frame: Baseline through Week 12
Change From Baseline in the Adapted 14-Item Mediterranean Diet Adherence Screener Score at Week 12
Time frame: Baseline and Week 12
Change From Baseline in the 12-Item Short Form Health Survey Physical Component Summary Score at Week 12
Time frame: Baseline and Week 12
Change From Baseline in the 12-Item Short Form Health Survey Mental Component Summary Score at Week 12
Time frame: Baseline and Week 12
Mean Item Score on the Study-Specific Dietary Adherence Self-Assessment Questionnaire
Time frame: Weeks 4, 8, and 12
Overall Self-Rated Dietary Adherence in the Intervention Group
Time frame: Weeks 4, 8, and 12
Usability of the NutriSteppe Application Assessed Using the System Usability Scale
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data may be shared with qualified researchers upon reasonable request after publication of the primary study results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Almaz Sharman, MD, PhD principal investigator
Kazakh Academy of Nutrition LLP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NutriSteppe Digital Dietary Intervention in people with Type 2 Diabetes Mellitus (T2DM) and Obesity (Disorder), run by Kazakh Academy of Nutrition at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayaulym Omirbekova (+77757211170, a.omirbekova@academypm.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.