Last reviewed · How we verify
NCT04745572
Development of an Adaptive Treatment for Weight Loss in People With Prediabetes
NA trial testing High Carbohydrate Diet in PreDiabetes in 90 participants. Completed in 21 November 2023.
21 November 2023
Quick facts
| Lead sponsor | University of Alabama at Birmingham |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 90 |
| Start date | 14 May 2021 |
| Primary completion | 21 November 2023 |
| Estimated completion | 21 November 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- High Carbohydrate Diet
- Reduced Carbohydrate Diet
Conditions studied
- PreDiabetes — all drugs for PreDiabetes →
- Obesity — all drugs for Obesity →
Sponsor
University of Alabama at Birmingham
Who can join
Adults 18 to 75, any sex, with PreDiabetes or Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This 16-week study will use an experimental approach called the Sequential Multiple Assignment Randomized Trial to help determine which combination and sequence of weight loss program features are most effective in people who are at risk for type 2 diabetes. Participants in the study will be initially randomized to consume either a high or reduced carbohydrate diet. After 4 weeks, participants will be identified as Responders (greater than or equal to 2.5% weight loss) or Non-Responders (less than 2.5% weight loss). Responders will continue with their initial randomized group for the remainder of the trial. Non-responders will be re-randomized to 2nd stage interventions of either including additional exercise counseling and training or beginning a time restricted eating protocol for the remainder of the trial.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Low-carbohydrate versus balanced-carbohydrate diets for reducing weight and cardiovascular risk.
Naude CE, Brand A, Schoonees A, Nguyen KA, et al · · 2022 · cited 46× · PMID 35088407 · DOI 10.1002/14651858.cd013334.pub2 -
Body Size Measurements Grouped Independently of Common Clinical Measures of Metabolic Health: An Exploratory Factor Analysis.
Ellison KM, El Zein A, Reynolds C, Ehrlicher SE, et al · · 2024 · cited 1× · PMID 39275189 · DOI 10.3390/nu16172874 -
Adaptive dietary and exercise strategies for weight loss in Adults with Prediabetes Trial (ADAPT): a sequential multiple assignment randomized trial.
Ellison KM, El Zein A, Baidwan NK, Ferguson CC, et al · · 2025 · PMID 40763896 · DOI 10.1016/j.ajcnut.2025.07.034 -
A Novel and Comprehensive Wellness Assessment for Lifestyle-Based Interventions.
Ellison KM, Smith KA, Fernández JR, Plaisance EP, et al · · 2024 · PMID 39529897 · DOI 10.1002/osp4.70022
Verify or expand the search:
- PubMed search for NCT04745572
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for PreDiabetes
Currently open trials in the same condition.
- NCT06897982 — Feasibility of a Nutrition Intervention for Patients With Prediabetes at a Federally Qualified Health Center · NA · recruiting
- NCT06967558 — The Role of Islet GLP-1 in the Pathogenesis of Prediabetes · Phase 2 · recruiting
- NCT06482944 — Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes · NA · recruiting
- NCT06989164 — Post Prandial Individual Responses to Different Foods · NA · recruiting
- NCT07254572 — Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes · Phase 4 · recruiting
Other University of Alabama at Birmingham trials
Trials by the same sponsor.
- NCT04922229 — Comparative Effectiveness in the Management of Irreversible Pulpitis · NA · not yet recruiting
- NCT05060380 — Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis · NA · withdrawn
- NCT04768777 — Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis · NA · not yet recruiting
- NCT06320951 — VITAL-IMPACT: Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine · Phase 2 · not yet recruiting
- NCT07564934 — Leveraging Extended Reality Exergaming and Telehealth to Improve Physical Activity and Health in Children With Disabilit · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04745572 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Alabama at Birmingham
- Last refreshed: 27 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04745572.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing