Clinical trial NCT03336411: A Personalized Diet Study to Reduce Glycemic Exposure
Official title: Personalized Technology-Supported Counseling to Reduce Glycemic Response in Dietary Weight Loss: The Personal Diet Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-diabetes
Overweight and Obesity
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: Weizmann Institute of Science
First posted: 2017-11-08
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this 2-phase, randomized clinical trial will be to examine the effects of two behavioral weight loss interventions on weight loss. This study will be conducted in 200 overweight or obese prediabetic individuals recruited from community-based settings.. Phase 1 will include 6-months of active intervention. Phase 2 will consist of 6-months of maintenance and observation. Measurements will occur at screening, baseline, 3, 6, and 12 months. Participants will be randomized with equal allocation to 2 groups: (1) a standardized behavioral weight loss intervention with a one-size-fits-all regimen that includes counseling about restriction of calories and calories from fat, and physical activity, delivered using mHealth technology, or (2) all of the elements of mHealth, plus personalized dietary recommendations to minimize glycemic response to meals. Participants will be required to attend 6 separate visits over both phases of the study.


Eligibility criteria: Inclusion Criteria:

* Healthy overweight or obese prediabetic (HbA1c \<8.0%)
* BMI ≥27 kg/m2
* Oral medications with metformin, sulfonylureas, DPP4 inhibitors
* Posses smartphone or use study loaner smartphone

Exclusion Criteria:

* unable or unwilling to provide informed consent
* unable to participate meaningfully in an intervention that involves self-monitoring using software available in English (e.g., due to uncorrected sight impairment, illiterate, non-English-speaking, dementia)
* unwilling to accept randomization assignment
* women who pregnant, or plan to become pregnant in the next 13 months, or who become pregnant during the study
* institutionalized (e.g., in a nursing home or personal care facility, or those who are incarcerated and have limited control over diet)
* unwilling to delay bariatric surgery for the next 12 months
* diagnosed with heart disease, kidney disease, or retinopathy, (to rule-out those with long-standing T2D)
* chronically active inflammatory or neoplastic disease in the past 3 years
* diagnosed with a chronic gastrointestinal disorder (e.g. inflammatory bowel disease or celiac disease)
* diagnosed with active infection requiring antibiotics in the last 3 months or who develop an active infection requiring antibiotics during the study
* taking medications containing acetaminophen and are unwilling or unable to discontinue its use during the study (acetaminophen affects the accuracy of the continuous glucose monitoring \[CGM\] device)
* taking chronic immunosuppressive medications or used them in the 3 months prior to participation, or during the study
* managing glycemia with insulin, GLP-I agonists (exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide), insulin secretagogues (Glimepiride, Glipizide, Glyburide, Repaglinide, Nateglinide), or SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, empagliflozin/metformin, dapagliflozin/metformin)
* prescribed medications expected to result in weight loss such as Orlistat, Naltrexone, Bupropion, Lorcaserin, Phentermine, Topiramate, or Liraglutide, and who are unwilling to delay treatment with these medications for the next 12 months
* +/- 5% weight change within last month at screening
* a eGFR \<60 mL/min/1.73m2
* younger than 18 or older than 80 years old.

Primary outcomes:
measure: Body weight, percent change
timeFrame: 6 months
Secondary outcomes:
measure: Body Composition
timeFrame: 6 & 12 months
measure: Metabolic Adaptation
timeFrame: 6 & 12 months
measure: Weight regain
timeFrame: 12 months
Other outcomes:
measure: Glycemic variability (GV )
timeFrame: 6 months
measure: RAGE/AGE/S100/A8/A9
timeFrame: 6 & 12 MONTHS
measure: Adipokines
timeFrame: 6 & 12 months
measure: Self-efficacy
timeFrame: 3,6, 12-months
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Medical Center, Department of Population Health
name: Mary Ann Sevick, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weizmann Institute of Science, Department of Computer Science and Applied Mathematics
name: Eran Segal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Popp CJ, Hu L, Kharmats AY, Curran M, Berube L, Wang C, Pompeii ML, Illiano P, St-Jules DE, Mottern M, Li H, Williams N, Schoenthaler A, Segal E, Godneva A, Thomas D, Bergman M, Schmidt AM, Sevick MA. Effect of a Personalized Diet to Reduce Postprandial Glycemic Response vs a Low-fat Diet on Weight Loss in Adults With Abnormal Glucose Metabolism and Obesity: A Randomized Clinical Trial. JAMA Netw Open. 2022 Sep 1;5(9):e2233760. doi: 10.1001/jamanetworkopen.2022.33760.
citation: Popp CJ, Zhou B, Manigrasso MB, Li H, Curran M, Hu L, St-Jules DE, Aleman JO, Vanegas SM, Jay M, Bergman M, Segal E, Sevick MA, Schmidt AM. Soluble Receptor for Advanced Glycation End Products (sRAGE) Isoforms Predict Changes in Resting Energy Expenditure in Adults with Obesity during Weight Loss. Curr Dev Nutr. 2022 Mar 29;6(5):nzac046. doi: 10.1093/cdn/nzac046. eCollection 2022 May.
citation: Popp CJ, Butler M, Curran M, Illiano P, Sevick MA, St-Jules DE. Evaluating steady-state resting energy expenditure using indirect calorimetry in adults with overweight and obesity. Clin Nutr. 2020 Jul;39(7):2220-2226. doi: 10.1016/j.clnu.2019.10.002. Epub 2019 Oct 14.
citation: Popp CJ, St-Jules DE, Hu L, Ganguzza L, Illiano P, Curran M, Li H, Schoenthaler A, Bergman M, Schmidt AM, Segal E, Godneva A, Sevick MA. The rationale and design of the personal diet study, a randomized clinical trial evaluating a personalized approach to weight loss in individuals with pre-diabetes and early-stage type 2 diabetes. Contemp Clin Trials. 2019 Apr;79:80-88. doi: 10.1016/j.cct.2019.03.001. Epub 2019 Mar 4.