A Personalized Diet Study to Reduce Glycemic Exposure



Status:Recruiting
Conditions:Obesity Weight Loss, Endocrine, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 80
Updated:4/17/2018
Start Date:December 12, 2017
End Date:September 2020
Contact:Mary Ann Sevick
Email:Personal.diet@nyumc.org
Phone:646-501-2606

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Personalized Technology-Supported Counseling to Reduce Glycemic Response in Dietary Weight Loss: The Personal Diet Study

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.


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.
We found this trial at
1
site
550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Mary Ann Sevick, MD
Phone: 646-501-2606
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