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A Randomized Controlled Pilot Study of the Food Order Behavioral Intervention in Prediabetes

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ClinicalTrials.gov Identifier: NCT03896360
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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).

Condition or disease Intervention/treatment Phase
Pre Diabetes Obesity Behavioral: Food order behavioral intervention plus standard care Behavioral: Standard Care Not Applicable

Detailed Description:
Intensive diet and lifestyle modifications have been shown to reduce the risk of progression to T2DM in several randomized controlled trials. Key components of standard nutritional counseling include reducing calorie intake and glycemic load. Sequential nutrient ingestion is a novel strategy found to attenuate the glycemic effect of a meal. Investigators have previously shown that ingestion of carbohydrates after protein or vegetables results in reduced glucose and insulin excursions over 180 min in patients with T2DM. In addition, investigators also found that levels of the hunger hormone ghrelin were more suppressed at the end of 3 hours after a meal. Furthermore, investigators found that the glycemic effects of food order apply to individuals with prediabetes as well. This study follows previous research on nutrient order and seeks to determine the metabolic effects of this behavioral intervention in the real world. The study will include two randomized groups who are overweight or obese and are diagnosed with prediabetes. The control group will receive standard nutritional counseling at the start of the study and no instructions to change food order behavior. The intervention group will receive regularly scheduled food order counseling over a period of 16 weeks in addition to standard nutritional counseling at baseline. Anthropometric and metabolic parameters, including insulin sensitivity, will be assessed at baseline and at 16 weeks. The primary aim of this study is to determine the proportion of subjects who achieve reversal of prediabetes at study completion and/ or who achieve a 0.2% reduction in hemoglobin A1c. If shown to be effective, this data will inform the design of larger study focused on diabetes prevention.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Pilot Study of the Food Order Behavioral Intervention in Prediabetes
Actual Study Start Date : February 28, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
Experimental: Food order behavioral intervention plus standard care
Subjects will receive standard nutrition counseling and additional carbohydrate‐last food order behavioral counseling.
Behavioral: Food order behavioral intervention plus standard care
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.

Standard care
Subjects will receive standard nutrition counseling.
Behavioral: Standard Care
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.




Primary Outcome Measures :
  1. Effect of food order counseling added to standard care on glucose tolerance in individuals with overweight/obesity and prediabetes [ Time Frame: 16 weeks ]
    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



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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% and 2 hour glucose between 140 - 199 mg/dl on OGTT
  • Weight stable (< 5% body weight change over preceding 6 months)
  • Provide valid informed consent

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896360


Locations
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United States, New York
Comprehensive Weight Control Center Recruiting
New York, New York, United States, 10065
Contact: Anthony Casper    646-962-2424    anc2088@med.cornell.edu   
Principal Investigator: Alpana P Shukla, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Alpana P Shukla, MD Weill Cornell Medicine

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03896360     History of Changes
Other Study ID Numbers: 1807019463
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases