NCT06902077

Brief Summary

The purpose of this project is to test the effect of a low carb diet compared to standard carb diet among adolescents with T2D over a 24-week period.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
21mo left

Started Nov 2025

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Nov 2025Dec 2027

First Submitted

Initial submission to the registry

March 7, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 30, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

November 25, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

December 8, 2025

Status Verified

December 1, 2025

Enrollment Period

1.8 years

First QC Date

March 7, 2025

Last Update Submit

December 1, 2025

Conditions

Type 2 Diabetes

Keywords

Pediatric type 2 diabetesType 2 Diabeteslow carb dietLow-Carbohydrate Dietary

Outcome Measures

Primary Outcomes (3)

  • Change in HbA1c

    HbA1c levels will be measured to assess long-term glycemic control. Unit of Measure: Percent (%).

    Base line, 3 months, 6 months

  • Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

    HOMA-IR will be calculated using fasting glucose and insulin values collected at baseline. The formula used is: HOMA-IR = (fasting insulin \[μU/mL\] × fasting glucose \[mg/dL\]) / 405. This index reflects hepatic insulin resistance. Units of Measure: Unitless index

    Base line, 3 months, 6 months

  • Whole Body Insulin Sensitivity Index (WBISI)

    WBISI will be calculated using values from the 2-hour Oral Glucose Tolerance Test (OGTT). The formula is: WBISI = 10,000 / √(fasting glucose × fasting insulin × mean OGTT glucose × mean OGTT insulin). This index reflects peripheral insulin sensitivity. Units of Measure: Unitless index

    Base line, 3 months, 6 months

Secondary Outcomes (4)

  • Change in BMI

    Base line, 3 months, 6 months

  • Change in blood pressure

    Base line, 3 months, 6 months

  • Change in lipid profile

    Base line, 3 months, 6 months

  • Change in body composition

    Base line, 3 months, 6 months

Study Arms (2)

Low carb diet

ACTIVE COMPARATOR

Participants in this group will limit the amount of carbohydrates they eat each day to 50-80 grams. This means eating fewer sugars and starches (like bread, pasta, rice, and sweets). Instead, meals will focus on protein, healthy fats, and non-starchy vegetables. Participants will track their food and meet with a dietitian to help them stick to the plan.

Behavioral: low carb diet

Standard of care

ACTIVE COMPARATOR

Participants in this group will follow the current standard diet for managing diabetes. This includes balanced meals with carbohydrates, protein, and fats, based on regular diabetes guidelines. Participants will track their food and meet with a dietitian to help them stay on track.

Behavioral: diabetic diet

Interventions

low carb dietBEHAVIORAL

diet based on low carb with max 50-80 grams of carbohydrates daily

Low carb diet
diabetic dietBEHAVIORAL

Balanced diet based on standard of care recommendations for type 2 diabetes

Standard of care

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 12-18
  • Diabetes diagnosis \>3 months to ensure stable baseline glycemic control
  • HbA1C between 6.5- 8.5%
  • BMI \>85th percentile
  • Negative pancreatic autoantibodies
  • Stable dose of anti-diabetic drugs GLP-1, metformin, SGLT-2 inhibitors, for 3 months

You may not qualify if:

  • Current insulin treatment
  • Renal impairment measured as creatinine \> 1 mg/dL
  • Hepatic dysfunction measured as AST and ALT \>100 IU/ml

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham/ Children's of Alabama

Birmingham, Alabama, 35233, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet, Diabetic

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Ortal Resnick, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ortal Resnick, MD

CONTACT

205-638-9107oresnick@uabmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow- Principal Investigator

Study Record Dates

First Submitted

March 7, 2025

First Posted

March 30, 2025

Study Start

November 25, 2025

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

December 8, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)