Validation of the Snouda Metabolic Score for Phenotyping and Guiding Reversal in Type 2 Diabetes

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Поведенческое Phenotype-Matched Dietary Protocol
  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).
• Поведенческое Structured Progressive Exercise Protocol
  A progressive exercise program combining resistance training and aerobic activity, delivered through the diabetesreversal.io platform with instructional videos and weekly progression targets.
• Пищевая добавка Targeted Nutritional Supplementation
  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.
• Поведенческое Structured Intermittent Fasting Protocol
  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.

Первичные конечные точки

• Change in HbA1c from Baseline to Week 24 [Срок оценки: Baseline and Week 24]
• Rate of Type 2 Diabetes Remission at Week 24 [Срок оценки: Week 24]

Вторичные конечные точки (7)

• Change in Fasting Insulin from Baseline to Week 24 [Срок оценки: Baseline and Week 24]
• Change in C-peptide from Baseline to Week 24 [Срок оценки: Baseline and Week 24]
• Change in High-Sensitivity C-Reactive Protein (hs-CRP) from Baseline to Week 24 [Срок оценки: Baseline and Week 24]
• Change in Fasting Morning Cortisol from Baseline to Week 24 [Срок оценки: Baseline and Week 24]
• Change in Body Weight from Baseline to Week 24 [Срок оценки: Baseline and Week 24]
• Change in Waist Circumference from Baseline to Week 24 [Срок оценки: Baseline and Week 24]
• SMS Phenotype Classification Accuracy [Срок оценки: Week 24]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

• Snouda Health Coaching Ltd — Manchester

Идентификаторы

NCT: NCT07606872 · SMS-VAL-2026-001 · 20261755

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗