Type 2 Diabetes Mellitus (T2DM)SMS-VALNCT07606872
Validation of the Snouda Metabolic Score for Phenotyping and Guiding Reversal in Type 2 Diabetes
A study testing Phenotype-Matched Dietary Protocol, Structured Progressive Exercise Protocol and Targeted Nutritional Supplementation in people with Type 2 Diabetes Mellitus (T2DM) and Insulin Resistance, run by Salah Snouda at 1 site in United Kingdom.
Trial summary
This study tests a new tool called the Snouda Metabolic Score (SMS) that helps doctors identify the specific metabolic problems driving Type 2 Diabetes in each individual patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Insulin Resistance, Metabolic Syndrome
- What is being tested?
- Phenotype-Matched Dietary Protocol, Structured Progressive Exercise Protocol and Targeted Nutritional Supplementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2026to Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of Type 2 Diabetes Mellitus (T2DM) by a licensed healthcare provider
- Age 18 years or older
- HbA1c between 6.5% and 11.0% at baseline
- Currently managed with lifestyle measures alone, or with oral glucose-lowering medications (metformin, SGLT2 inhibitors, DPP-4 inhibitors, or sulfonylureas)
- Ability to access and use the diabetesreversal.io digital platform
- Willingness to perform daily self-monitoring of blood glucose
- Willingness to complete laboratory blood tests (Genesis Biomarker Panel) at baseline and Week 24 at own expense
- Able to provide written informed consent
Who cannot join
- Type 1 Diabetes Mellitus or Latent Autoimmune Diabetes in Adults (LADA)
- Currently pregnant or breastfeeding
- Currently using insulin therapy
- Currently using GLP-1 receptor agonists (e.g., semaglutide, liraglutide)
- HbA1c greater than 11.0% at baseline
- History of severe hypoglycemia requiring third-party assistance in the past 12 months
Show all 11Show fewer
- Active malignancy or receiving chemotherapy or radiation therapy
- Severe renal impairment (eGFR less than 30 mL/min/1.73m²)
- Severe hepatic impairment
- Active eating disorder
- Any condition that in the opinion of the investigator would make participation unsafe or interfere with study completion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Interventional Clinical Validation Study of the Snouda Metabolic Score (SMS) as a Phenotyping and Protocol-Targeting Instrument in Adults With Type 2 Diabetes Mellitus
This study tests a new tool called the Snouda Metabolic Score (SMS) that helps doctors identify the specific metabolic problems driving Type 2 Diabetes in each individual patient. Instead of treating all diabetic patients the same way, the SMS classifies patients into one of several metabolic phenotypes - patterns of dysfunction across five body systems: insulin resistance, chronic inflammation, hormonal disruption, gut microbiome imbalance, and mitochondrial dysfunction.
Once classified, each participant follows a personalized 24-week lifestyle and nutritional protocol targeting their specific phenotype. The protocol includes dietary changes, structured exercise, targeted nutritional supplements, and optional intermittent fasting. Participants track their blood glucose daily and complete biomarker blood tests at the start and end of the study.
Read more
The main goal is to determine whether the SMS tool accurately identifies metabolic phenotypes and whether phenotype-matched protocols produce better outcomes than standard approaches. The study measures changes in HbA1c, fasting insulin, C-peptide, inflammation markers, and whether participants achieve Type 2 Diabetes remission - defined as HbA1c below 6.5% without glucose-lowering medication.
The study is conducted entirely online through the diabetesreversal.io platform. There are no clinic visits required. Participants must be adults aged 18 or older with a confirmed Type 2 Diabetes diagnosis and must not be pregnant or breastfeeding.
Read the detailed description
Type 2 Diabetes Mellitus (T2DM) is a heterogeneous metabolic disorder driven by multiple overlapping physiological dysfunctions. Standard clinical management focuses on glycemic control through pharmacotherapy but does not address the underlying mechanistic drivers of the disease. This results in lifelong medication dependency and progressive disease burden rather than reversal.
The Snouda Metabolic Score (SMS) is a hybrid composite-to-binary diagnostic instrument designed to phenotype T2DM patients across five mechanistic pillars: (A) Insulin Resistance and Hyperinsulinemia, (B) Chronic Low-Grade Inflammation, (C) Hormonal and HPA Axis Dysregulation, (D) Gut Microbiome Dysbiosis, and (E) Mitochondrial Dysfunction and Oxidative Stress. Each pillar is scored using a combination of objective laboratory biomarkers (weighted 60%) and clinician-administered patient-reported secondary criteria (weighted 40%), generating a Confirmed Phenotype code that guides precision protocol targeting.
This prospective interventional study enrolls 50 adult participants with confirmed T2DM. Following SMS phenotyping at baseline, participants are assigned to a 24-week personalized intervention protocol matched to their Confirmed Phenotype. The intervention comprises four components: (1) a structured dietary protocol based on phenotype (low-carbohydrate, anti-inflammatory, or mitochondrial support diet); (2) a progressive exercise protocol; (3) targeted nutritional supplementation based on identified deficiencies; and (4) optional structured intermittent fasting with full safety protocols.
Primary outcomes include change in HbA1c from baseline to Week 24, proportion of participants achieving T2DM remission (HbA1c less than 6.5% off glucose-lowering medication), and SMS phenotype classification accuracy. Secondary outcomes include changes in fasting insulin, C-peptide, hs-CRP, morning cortisol, body weight, waist circumference, blood pressure, and participant-reported quality of life.
The study is conducted entirely through the diabetesreversal.io digital platform. Participants complete the SMS assessment online, receive their personalized protocol through the platform, submit weekly check-ins, and upload self-measured physical assessments and blood glucose readings. Laboratory biomarker testing (Genesis Biomarker Panel) is performed at a local laboratory of the participant's choice at baseline and Week 24, with costs borne by the participant.
Safety oversight includes daily glucose monitoring protocols, a hypoglycemia escalation protocol, mandatory physician consultation prior to fasting periods, and independent medical monitoring of all serious adverse events. The study has received Deferred Approval from WCG Institutional Review Board (IRB Tracking Number 20261755).
- Being tested
- Phenotype-Matched Dietary Protocol, Structured Progressive Exercise Protocol, Targeted Nutritional Supplementation, Structured Intermittent Fasting Protocol
- Keywords
- Diabetes reversal, Metabolic phenotyping, Snouda Metabolic Score, Lifestyle intervention, HbA1c reduction, Intermittent fasting, Low-carbohydrate diet, Chronic inflammation, Mitochondrial dysfunction, Gut microbiome
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance, Metabolic Syndrome, Intermittent Fasting, Mitochondrial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenotype-Matched Dietary ProtocolBehavioural
A structured dietary plan tailored to the participant's SMS Confirmed Phenotype. Options include low-carbohydrate diet (Pillar A dominant), anti-inflammatory diet (Pillar B dominant), cortisol-regulating diet (Pillar C dominant), prebiotic/probiotic-rich diet (Pillar D dominant), or mitochondrial support diet (Pillar E dominant).
Structured Progressive Exercise ProtocolBehavioural
A progressive exercise program combining resistance training and aerobic activity, delivered through the diabetesreversal.io platform with instructional videos and weekly progression targets.
Targeted Nutritional SupplementationDietary supplement
Nutritional supplements selected based on the participant's SMS phenotype and identified deficiencies. May include magnesium, berberine, omega-3 fatty acids, vitamin D, CoQ10, or probiotic formulations depending on the Confirmed Phenotype.
Structured Intermittent Fasting ProtocolBehavioural
Optional structured intermittent fasting periods with a mandatory 24-hour fasting safety protocol including pre-fast physician consultation, 4-hourly glucose monitoring, defined stop criteria, and carbohydrate availability requirements.
| Study group | Role | What they receive |
|---|---|---|
| Phenotype-Matched Lifestyle Intervention | Experimental | Participants undergo SMS phenotyping at baseline and receive a 24-week personalized protocol matched to their Confirmed Phenotype code. The protocol includes a phenotype-specific dietary plan, structured progressive exercise, targeted nutritional supplementation, and optional structured intermittent fasting with full safety protocols. Receives: Behavioral: Phenotype-Matched Dietary Protocol; Behavioral: Structured Progressive Exercise Protocol; Dietary Supplement: Targeted Nutritional Supplementation; Behavioral: Structured Intermittent Fasting Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c from Baseline to Week 24
Change in glycated hemoglobin (HbA1c, %) measured via laboratory blood test at baseline and Week 24, as an indicator of long-term glycemic control improvement.
Measured: Baseline and Week 24
Rate of Type 2 Diabetes Remission at Week 24
Proportion of participants achieving T2DM remission, defined as HbA1c below 6.5% without glucose-lowering medication for a minimum of 3 months, as assessed at Week 24.
Measured: Week 24
Secondary outcomes (7)
Change in Fasting Insulin from Baseline to Week 24
Measured: Baseline and Week 24
Change in C-peptide from Baseline to Week 24
Measured: Baseline and Week 24
Change in High-Sensitivity C-Reactive Protein (hs-CRP) from Baseline to Week 24
Measured: Baseline and Week 24
Change in Fasting Morning Cortisol from Baseline to Week 24
Measured: Baseline and Week 24
Change in Body Weight from Baseline to Week 24
Measured: Baseline and Week 24
Change in Waist Circumference from Baseline to Week 24
Measured: Baseline and Week 24
SMS Phenotype Classification Accuracy
Proportion of participants whose SMS Confirmed Phenotype code at baseline correctly predicts the dominant mechanistic driver as confirmed by biomarker response pattern at Week 24.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants undergo SMS phenotyping at baseline and receive a 24-week personalized intervention protocol matched to their Confirmed Phenotype code. There is no randomization or control arm; this is a single-arm pre-post validation study.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salah Snouda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Salah Snouda, Snouda Health Coaching Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606872
- Sponsor's protocol ID
- SMS-VAL-2026-001
- Other IDs
- 20261755
- Acronym
- SMS-VAL
- Status last verified
- Aug 2026
- First submitted
- 19 May 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Interventional Clinical Validation Study of the Snouda Metabolic Score (SMS) as a Phenotyping and Protocol-Targeting Instrument in Adults With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07606872
- Acronym / sponsor ID
- SMS-VAL / SMS-VAL-2026-001
- Keywords
- Diabetes reversal, Metabolic phenotyping, Snouda Metabolic Score, Lifestyle intervention, HbA1c reduction, Intermittent fasting, Low-carbohydrate diet, Chronic inflammation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Salah SnoudaUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 26 May 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.
This study tests a new tool called the Snouda Metabolic Score (SMS) that helps doctors identify the specific metabolic problems driving Type 2 Diabetes in each individual patient. Instead of treating all diabetic patients the same way, the SMS classifies patients into one of several metabolic phenotypes - patterns of dysfunction across five body systems: insulin resistance, chronic inflammation, hormonal disruption, gut microbiome imbalance, and mitochondrial dysfunction.
Once classified, each participant follows a personalized 24-week lifestyle and nutritional protocol targeting their specific phenotype. The protocol includes dietary changes, structured exercise, targeted nutritional supplements, and optional intermittent fasting. Participants track their blood glucose daily and complete biomarker blood tests at the start and end of the study.
The main goal is to determine whether the SMS tool accurately identifies metabolic phenotypes and whether phenotype-matched protocols produce better outcomes than standard approaches. The study measures changes in HbA1c, fasting insulin, C-peptide, inflammation markers, and whether participants achieve Type 2 Diabetes remission - defined as HbA1c below 6.5% without glucose-lowering medication.
The study is conducted entirely online through the diabetesreversal.io platform. There are no clinic visits required. Participants must be adults aged 18 or older with a confirmed Type 2 Diabetes diagnosis and must not be pregnant or breastfeeding.
Detailed description
Type 2 Diabetes Mellitus (T2DM) is a heterogeneous metabolic disorder driven by multiple overlapping physiological dysfunctions. Standard clinical management focuses on glycemic control through pharmacotherapy but does not address the underlying mechanistic drivers of the disease. This results in lifelong medication dependency and progressive disease burden rather than reversal.
The Snouda Metabolic Score (SMS) is a hybrid composite-to-binary diagnostic instrument designed to phenotype T2DM patients across five mechanistic pillars: (A) Insulin Resistance and Hyperinsulinemia, (B) Chronic Low-Grade Inflammation, (C) Hormonal and HPA Axis Dysregulation, (D) Gut Microbiome Dysbiosis, and (E) Mitochondrial Dysfunction and Oxidative Stress. Each pillar is scored using a combination of objective laboratory biomarkers (weighted 60%) and clinician-administered patient-reported secondary criteria (weighted 40%), generating a Confirmed Phenotype code that guides precision protocol targeting.
This prospective interventional study enrolls 50 adult participants with confirmed T2DM. Following SMS phenotyping at baseline, participants are assigned to a 24-week personalized intervention protocol matched to their Confirmed Phenotype. The intervention comprises four components: (1) a structured dietary protocol based on phenotype (low-carbohydrate, anti-inflammatory, or mitochondrial support diet); (2) a progressive exercise protocol; (3) targeted nutritional supplementation based on identified deficiencies; and (4) optional structured intermittent fasting with full safety protocols.
Primary outcomes include change in HbA1c from baseline to Week 24, proportion of participants achieving T2DM remission (HbA1c less than 6.5% off glucose-lowering medication), and SMS phenotype classification accuracy. Secondary outcomes include changes in fasting insulin, C-peptide, hs-CRP, morning cortisol, body weight, waist circumference, blood pressure, and participant-reported quality of life.
The study is conducted entirely through the diabetesreversal.io digital platform. Participants complete the SMS assessment online, receive their personalized protocol through the platform, submit weekly check-ins, and upload self-measured physical assessments and blood glucose readings. Laboratory biomarker testing (Genesis Biomarker Panel) is performed at a local laboratory of the participant's choice at baseline and Week 24, with costs borne by the participant.
Safety oversight includes daily glucose monitoring protocols, a hypoglycemia escalation protocol, mandatory physician consultation prior to fasting periods, and independent medical monitoring of all serious adverse events. The study has received Deferred Approval from WCG Institutional Review Board (IRB Tracking Number 20261755).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants undergo SMS phenotyping at baseline and receive a 24-week personalized intervention protocol matched to their Confirmed Phenotype code. There is no randomization or control arm; this is a single-arm pre-post validation study.
| Arm | Type | Receives |
|---|---|---|
| Phenotype-Matched Lifestyle Intervention | Experimental | Behavioral: Phenotype-Matched Dietary Protocol, Behavioral: Structured Progressive Exercise Protocol, Dietary Supplement: Targeted Nutritional Supplementation, Behavioral: Structured Intermittent Fasting ProtocolParticipants undergo SMS phenotyping at baseline and receive a 24-week personalized protocol matched to their Confirmed Phenotype code. The protocol includes a phenotype-specific dietary plan, structured progressive exercise, targeted nutritional supplementation, and optional structured intermittent fasting with full safety protocols. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Confirmed diagnosis of Type 2 Diabetes Mellitus (T2DM) by a licensed healthcare provider
- Age 18 years or older
- HbA1c between 6.5% and 11.0% at baseline
- Currently managed with lifestyle measures alone, or with oral glucose-lowering medications (metformin, SGLT2 inhibitors, DPP-4 inhibitors, or sulfonylureas)
- Ability to access and use the diabetesreversal.io digital platform
Key exclusion criteria (11 listed)
- Type 1 Diabetes Mellitus or Latent Autoimmune Diabetes in Adults (LADA)
- Currently pregnant or breastfeeding
- Currently using insulin therapy
- Currently using GLP-1 receptor agonists (e.g., semaglutide, liraglutide)
- HbA1c greater than 11.0% at baseline
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 |
|---|---|---|
| Phenotype-Matched Dietary ProtocolA structured dietary plan tailored to the participant's SMS Confirmed Phenotype. Options include low-carbohydrate diet (Pillar A dominant), anti-inflammatory diet (Pillar B dominant), cortisol-regulating diet (Pillar C dominant), prebiotic/probiotic-rich diet (Pillar D dominant), or mitochondrial support diet (Pillar E dominant). | Behavioural | Phenotype-Matched Lifestyle Intervention |
| Structured Progressive Exercise ProtocolA progressive exercise program combining resistance training and aerobic activity, delivered through the diabetesreversal.io platform with instructional videos and weekly progression targets. | Behavioural | Phenotype-Matched Lifestyle Intervention |
| Targeted Nutritional SupplementationNutritional supplements selected based on the participant's SMS phenotype and identified deficiencies. May include magnesium, berberine, omega-3 fatty acids, vitamin D, CoQ10, or probiotic formulations depending on the Confirmed Phenotype. | Dietary supplement | Phenotype-Matched Lifestyle Intervention |
| Structured Intermittent Fasting ProtocolOptional structured intermittent fasting periods with a mandatory 24-hour fasting safety protocol including pre-fast physician consultation, 4-hourly glucose monitoring, defined stop criteria, and carbohydrate availability requirements. | Behavioural | Phenotype-Matched Lifestyle Intervention |
Primary outcome
Change in HbA1c from Baseline to Week 24
Time frame: Baseline and Week 24
Change in glycated hemoglobin (HbA1c, %) measured via laboratory blood test at baseline and Week 24, as an indicator of long-term glycemic control improvement.
Rate of Type 2 Diabetes Remission at Week 24
Time frame: Week 24
Proportion of participants achieving T2DM remission, defined as HbA1c below 6.5% without glucose-lowering medication for a minimum of 3 months, as assessed at Week 24.
7 secondary outcomes
Change in Fasting Insulin from Baseline to Week 24
Time frame: Baseline and Week 24
Change in C-peptide from Baseline to Week 24
Time frame: Baseline and Week 24
Change in High-Sensitivity C-Reactive Protein (hs-CRP) from Baseline to Week 24
Time frame: Baseline and Week 24
Change in Fasting Morning Cortisol from Baseline to Week 24
Time frame: Baseline and Week 24
Change in Body Weight from Baseline to Week 24
Time frame: Baseline and Week 24
Change in Waist Circumference from Baseline to Week 24
Time frame: Baseline and Week 24
SMS Phenotype Classification Accuracy
Time frame: Week 24
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 18 Aug 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phenotype-Matched Dietary Protocol, Structured Progressive Exercise Protocol and Targeted Nutritional Supplementation in people with Type 2 Diabetes Mellitus (T2DM) and Insulin Resistance, run by Salah Snouda at 1 site in United Kingdom.
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 8 inclusion and 11 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: enrolling by invitation, as of the sponsor's last update on 18 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 United Kingdom. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c from Baseline to Week 24 (time frame: Baseline and Week 24). The study lists 2 primary outcomes in all. 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 18 Aug 2026.