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

NCT07606872 | Not Yet Recruiting

• 2 other identifiers: SMS-VAL-2026-00120261755
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Type 2 Diabetes Mellitus (T2DM); Insulin Resistance; Metabolic Syndrome

Keywords

Diabetes reversal; Metabolic phenotyping; Snouda Metabolic Score; Lifestyle intervention; HbA1c reduction; Intermittent fasting; Low-carbohydrate diet; Chronic inflammation; Mitochondrial dysfunction; Gut microbiome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

Study Arms (1)

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.

Behavioral: Phenotype-Matched Dietary Protocol; Behavioral: Structured Progressive Exercise Protocol; Dietary Supplement: Targeted Nutritional Supplementation; Behavioral: Structured Intermittent Fasting Protocol

Interventions

Phenotype-Matched Dietary Protocol BEHAVIORAL

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).

Phenotype-Matched Lifestyle Intervention

Structured Intermittent Fasting Protocol BEHAVIORAL

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.

Phenotype-Matched Lifestyle Intervention

Structured Progressive Exercise Protocol BEHAVIORAL

A progressive exercise program combining resistance training and aerobic activity, delivered through the diabetesreversal.io platform with instructional videos and weekly progression targets.

Phenotype-Matched Lifestyle Intervention

Targeted Nutritional Supplementation DIETARY_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.

Phenotype-Matched Lifestyle Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Salah Snouda: lead

Study Sites (1)

Snouda Health Coaching Ltd

Manchester, England, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance; Metabolic Syndrome; Intermittent Fasting; Mitochondrial Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Fasting; Feeding Behavior; Behavior

Central Study Contacts

Salah Snouda, Medical Degree

CONTACT

+44 7846 032836; dr.snouda@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)