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.

Study Overview

• Status: Not yet recruiting
• Conditions: Metabolic Syndrome; Insulin Resistance; Type 2 Diabetes Mellitus (T2DM)
• Intervention / Treatment: Behavioral: Phenotype-Matched Dietary Protocol; Behavioral: Structured Progressive Exercise Protocol; Dietary supplement: Targeted Nutritional Supplementation; Behavioral: Structured Intermittent Fasting Protocol

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Salah Snouda, Medical Degree; Phone Number: +44 7846 032836; Email: dr.snouda@hotmail.com

Study Locations

• United Kingdom
  • England
    • Manchester, England, United Kingdom
      • Snouda Health Coaching Ltd
      • Contact: Salah Snouda, Medical Degree; Phone Number: +44 7846 032836; Email: dr.snouda@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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).; Behavioral: 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.; Dietary supplement: 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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fasting Insulin from Baseline to Week 24		Baseline and Week 24
Change in C-peptide from Baseline to Week 24		Baseline and Week 24
Change in High-Sensitivity C-Reactive Protein (hs-CRP) from Baseline to Week 24		Baseline and Week 24
Change in Fasting Morning Cortisol from Baseline to Week 24		Baseline and Week 24
Change in Body Weight from Baseline to Week 24		Baseline and Week 24
Change in Waist Circumference from Baseline to Week 24		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.	Week 24

Collaborators and Investigators

• Sponsor: Salah Snouda

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: May 19, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Mitochondrial dysfunction; Lifestyle intervention; Gut microbiome; Chronic inflammation; Intermittent fasting; Low-carbohydrate diet; HbA1c reduction; Diabetes reversal; Metabolic phenotyping; Snouda Metabolic Score
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Hyperinsulinism; Behavior; Nutritional and Metabolic Diseases; Feeding Behavior; Fasting; Diabetes Mellitus, Type 2; Metabolic Syndrome; Insulin Resistance; Mitochondrial Diseases; Intermittent Fasting
• Other Study ID Numbers: SMS-VAL-2026-001; 20261755 (Other Identifier: WCG IRB Tracking Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No