Study of the Food Order Behavioral Intervention in Prediabetes

NCT03896360 | Completed

• 1 other identifier: 1807019463
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators have previously shown that eating carbohydrates after protein or vegetables resulted in reduced glucose and insulin excursions over 180 min in patients with T2DM and in individuals with prediabetes as well. This is an open label, randomized controlled pilot study to assess the efficacy of carbohydrate-last food order behavior in reducing the risk of progression to type 2 diabetes (T2DM).

Conditions

Pre Diabetes; Obesity

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving a normal 2-hour glucose (less than 140mg/dl) and/ or greater than or equal to 15% improvement in 2-hour glucose

  Effect of food order counseling added to standard care on glucose tolerance in individuals with overweight/obesity and prediabetes as measured by the proportion of participants achieving a normal 2-hour glucose (less than 140mg/dl) and/ or greater than or equal to 15% improvement in 2-hour glucose

  16 weeks

Study Arms (2)

Food order behavioral intervention plus standard care

EXPERIMENTAL

Subjects will receive standard nutrition counseling and additional carbohydrate-last food order behavioral counseling.

Behavioral: Food order behavioral intervention plus standard care

Standard care

OTHER

Subjects will receive standard nutrition counseling.

Behavioral: Standard Care

Interventions

Food order behavioral intervention plus standard care BEHAVIORAL

Subjects in the Food order behavioral intervention plus standard care will receive standard counseling by a registered dietitian and additional carbohydrate last food order behavioral counseling by a member of the research team at baseline and Weeks 4, 8 and 12.

Food order behavioral intervention plus standard care

Standard Care BEHAVIORAL

Subjects will receive standard counseling by a registered dietitian at the baseline visit. Standard counseling will be similarly reinforced at weeks 4, 8 and 12.

Standard care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects who are 21 years of age or older
• BMI 25-40 kg/m2
• Pre-diabetes defined by an HbA1c of 5.7-6.4%
• Weight stable (\< 5% body weight change over preceding 6 months)
• Provide valid informed consent

You may not qualify if:

• Previous diagnosis of T2DM or Hb1A1c greater than or equal to 6.5% or fasting glucose \> 125mg/dl on screening or 2 hour glucose greater than or equal to 200 mg/dl on OGTT
• Patients who are on any oral/ injectable medications used to treat diabetes including metformin, sulfonylureas, DPP-4 inhibitors, GLP-1 analogs, SGLT2 inhibitors, glitazones and insulin
• Patients on over the counter or approved weight loss medications
• Pregnant or lactating females
• Previous bariatric surgery
• Psychotropic and/or other medications known to significantly impact weight unless on stable dose for 6 months
• eGFR \< 45ml/min
• Significant hepatic, cardiac, gastrointestinal, neurologic or other medical illness that would preclude participation in the study
• Untreated hypothyroidism or other endocrine disorders
• Non-English speaking patients
• Any patient deemed unsuitable in the investigator's opinion

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Louis and Rachel Rudin Foundation: collaborator

Study Sites (1)

Comprehensive Weight Control Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Glucose Intolerance; Obesity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Alpana P Shukla, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: March 29, 2019
• Study Start: February 28, 2019
• Primary Completion: January 21, 2022
• Study Completion: January 21, 2022
• Last Updated: February 3, 2022

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)