Validation of the Snouda Metabolic Score for Phenotyping and Guiding Reversal in Type 2 Diabetes (SMS-VAL)
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.
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.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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).
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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England
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Manchester, England, Verenigd Koninkrijk
- Snouda Health Coaching Ltd
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Phenotype-Matched Lifestyle Intervention
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.
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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).
A progressive exercise program combining resistance training and aerobic activity, delivered through the diabetesreversal.io
platform with instructional videos and weekly progression targets.
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.
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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in HbA1c from Baseline to Week 24
Tijdsspanne: Baseline and Week 24
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Change in glycated hemoglobin (HbA1c, %) measured via laboratory blood test at baseline and Week 24, as an indicator of long-term glycemic control improvement.
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Baseline and Week 24
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Rate of Type 2 Diabetes Remission at Week 24
Tijdsspanne: Week 24
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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.
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Week 24
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Fasting Insulin from Baseline to Week 24
Tijdsspanne: Baseline and Week 24
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Baseline and Week 24
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Change in C-peptide from Baseline to Week 24
Tijdsspanne: Baseline and Week 24
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Baseline and Week 24
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Change in High-Sensitivity C-Reactive Protein (hs-CRP) from Baseline to Week 24
Tijdsspanne: Baseline and Week 24
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Baseline and Week 24
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Change in Fasting Morning Cortisol from Baseline to Week 24
Tijdsspanne: Baseline and Week 24
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Baseline and Week 24
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Change in Body Weight from Baseline to Week 24
Tijdsspanne: Baseline and Week 24
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Baseline and Week 24
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Change in Waist Circumference from Baseline to Week 24
Tijdsspanne: Baseline and Week 24
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Baseline and Week 24
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SMS Phenotype Classification Accuracy
Tijdsspanne: Week 24
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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.
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Week 24
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SMS-VAL-2026-001
- 20261755 (Andere identificatie: WCG IRB Tracking Number)
Plan Individuele Deelnemersgegevens (IPD)
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Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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