Personalized Meal Timing and Walking Based on Glucose Patterns in Adults With Prediabetes

NCT07618663 | Recruiting

• 2 other identifiers: SH-34988909SIAC-02392
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test whether glucose sensor data can be used to identify the time of day when adults with prediabetes are most likely to have high blood sugar after meals. Participants will first wear a continuous glucose monitor and wrist activity monitor and record meal times for 10 days. These data will be used to classify each participant's personal "glycemic vulnerability window," such as morning, evening, or generally variable patterns. Participants will then be randomly assigned to either personalized meal timing plus a short walk after their most vulnerable meal, or to an attention-matched control group receiving sleep hygiene and general step-count advice. The main outcome will be the change in post-meal glucose exposure during each participant's vulnerable window after 4 weeks.

Conditions

Prediabetes; Prediabetes (Insulin Resistance, Impaired Glucose Tolerance); Prediabetes or Diabetes

Keywords

Prediabetes; Continuous Glucose Monitoring; Precision Lifestyle Medicine; Meal Timing; Glycemic Variability

Outcome Measures

Primary Outcomes (1)

• Change in Vulnerable-Window Postprandial Glucose Incremental Area Under the Curve

  Change from baseline run-in period to week 4 in mean postprandial glucose incremental area under the curve during each participant's pre-specified highest glycemic vulnerability window. Postprandial glucose incremental area under the curve will be calculated from continuous glucose monitoring data over 120 minutes after logged meals using the trapezoidal rule.

  Baseline run-in period to Week 4, unit of measure: mg/dL·min

Study Arms (2)

Phenotype-Guided Meal Timing and Postprandial Walking

EXPERIMENTAL

Participants will receive personalized lifestyle guidance based on their CGM-derived circadian glycemic vulnerability phenotype. They will be advised to shift their highest glycemic-load meal away from their highest-vulnerability window and toward their lowest-vulnerability window, and to perform a 10-minute brisk walk within 30 minutes after the meal occurring in their highest-vulnerability window.

Behavioral: Phenotype-Guided Meal Timing and Postprandial Walking

Attention-Matched Sleep Hygiene and Step-Count Advice

ACTIVE COMPARATOR

Participants will receive standardized sleep hygiene advice and general step-count guidance matched for contact time with the intervention group. They will not receive meal-timing advice, carbohydrate-timing advice, or postprandial walking instructions.

Behavioral: Sleep Hygiene and Step-Count Advice

Interventions

Phenotype-Guided Meal Timing and Postprandial Walking BEHAVIORAL

Participants randomized to this arm will receive personalized lifestyle guidance based on their CGM-derived circadian glycemic vulnerability phenotype. During the 10-day run-in period, continuous glucose monitoring, wrist actigraphy, and timestamped meal-photo logs will be used to identify the time window in which each participant has the greatest postprandial glucose exposure. Participants will be advised to shift their highest glycemic-load meal away from their highest-vulnerability window and toward their lowest-vulnerability window where feasible. They will also be instructed to perform a 10-minute brisk walk within 30 minutes after the meal occurring in their highest-vulnerability window on at least 5 days per week. The intervention will be delivered through structured dietitian counseling sessions and brief weekly check-in calls. No calorie restriction, prescribed macronutrient diet, or weight-loss target will be imposed.

Also known as: Phenotype-Guided Meal Timing, Postprandial Walking

Phenotype-Guided Meal Timing and Postprandial Walking

Sleep Hygiene and Step-Count Advice BEHAVIORAL

Participants randomized to the active comparator arm will receive standardized sleep hygiene and general physical activity guidance matched for contact time with the intervention arm. Sleep hygiene advice will include maintaining regular sleep and wake times, aiming for adequate sleep duration, and reducing screen exposure before bedtime. Participants will also be advised to increase their average daily step count by approximately 10% above their run-in baseline, with steps distributed freely throughout the day. This arm will not include any advice on meal timing, carbohydrate timing, glycemic vulnerability windows, or postprandial walking. The intervention will be delivered through structured dietitian counseling sessions and brief weekly check-in calls.

Also known as: Sleep Hygiene, Step-Count Advice

Attention-Matched Sleep Hygiene and Step-Count Advice

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 30 to 70 years
• Prediabetes, defined as either:
• HbA1c 5.7% to 6.4% within 3 months of screening, or
• Fasting plasma glucose 100 to 125 mg/dL on two separate occasions
• Body mass index 23 to 40 kg/m²
• Owns a smartphone compatible with study applications
• Willing to wear a continuous glucose monitor and wrist activity monitor during the study period
• Willing to record meals using timestamped meal-photo logging
• Able to provide written informed consent

You may not qualify if:

• Current or prior diagnosis of type 1 diabetes or type 2 diabetes
• Use of glucose-lowering medication within the past 3 months
• Use of systemic corticosteroid medication within the past 3 months
• Use of prescription weight-loss medication within the past 3 months
• Current shift work
• Transmeridian travel across more than 2 time zones within 4 weeks before enrollment
• Known untreated or unstable sleep disorder, including obstructive sleep apnea, narcolepsy, or insomnia disorder
• Pregnancy, planned pregnancy, or breastfeeding
• Gastrointestinal disease or surgery likely to affect nutrient absorption
• Current participation in a structured dietary or exercise intervention program
• Estimated glomerular filtration rate less than 60 mL/min/1.73 m²
• Inability or unwillingness to comply with continuous glucose monitoring, wrist actigraphy, meal logging, or study visits

Sponsors & Collaborators

• Shifa International Hospital: lead

Study Sites (1)

Shifa International hospital

Lahore, Shaikhupura, 50, Pakistan

RECRUITING

MeSH Terms

Conditions

Prediabetic State; Insulin Resistance; Glucose Intolerance; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Hyperglycemia

Central Study Contacts

Nadia Hussain, MD, PhD

CONTACT

0505440153; nadia.hussain@aau.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and intervention staff cannot be masked because of the behavioral nature of the intervention. Outcome assessors responsible for CGM data extraction, dried-blood-spot biomarker analysis, and endpoint computation will remain masked to group allocation. The trial statistician will analyze the primary endpoint using coded treatment groups until the statistical analysis plan is finalized.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical director

Model Details: Participants with prediabetes will undergo a 10-day blinded run-in period with continuous glucose monitoring, wrist actigraphy, and meal-photo logging to identify individual circadian glycemic vulnerability patterns. After phenotype classification, participants will be randomized in a 1:1 ratio to either phenotype-guided personalized meal timing plus targeted postprandial walking, or to an attention-matched active control group receiving sleep hygiene and general step-count advice.

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 1, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)