Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

ACT1ON Phase 2 (SMART Pilot) and Phase 3 (Efficacy Trial Development) (ACT1ON DP3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03651622
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : January 9, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
An initial pilot and feasibility study will be conducted using a Sequential, Multiple Assignment, Randomized Trial (SMART) design to identify acceptable and effective dietary strategies to optimize both glycemic control and weight management in young adults with Type 1 diabetes (T1D). This pilot trial will include a ten-and-a-half month behavioral intervention, with co-primary outcomes of glycemic control (HbA1C and hypoglycemia) and weight loss. The pilot trial will assess acceptability and adherence to three distinct, evidence-based dietary approaches designed to address weight management and glycemic control. Behavioral counseling strategies, use of carbohydrate counting for insulin dosing, and encouragement of physical activity will be the same across the three dietary approaches.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Overweight and Obesity Behavioral: Hypocaloric, low carbohydrate diet Behavioral: Hypocaloric, moderate low fat diet Behavioral: Mediterranean diet, no caloric restriction Not Applicable

Detailed Description:

Eighty-four participants will be randomized in total; 42 recruited at the University of North Carolina (UNC), 42 recruited at Stanford.

Procedures (methods):

Three distinct dietary approaches will be tested. Dietary approaches are as follows:

Diet 1: hypocaloric, moderate low fat (30% calories from fat) weight management based on the Look AHEAD study Diet 2: hypocaloric, low carbohydrate (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat) Diet 3: advice to select a healthy Mediterranean dietary pattern with no caloric restriction

Participants will complete measurement visits at baseline (-14 days), 3 mos, 6.5 mos, and 10 mos

Participants will complete a total of 23 intervention sessions over an approximately 10-and-a-half month period (Eight in person sessions and 15 telephone check-ins)

Participants will be randomized to one of the three diets for a minimum of a three-and-a-half month period. Re-randomization is possible following the 3 month and/or 6.5 month measurement visits. Re-randomization is based on acceptability of diet (self-report), non-severe hypoglycemic events (self-report), and not achieving significant weight change (defined as losing at least 2% of body weight from previous study visit), and worsening glycemic control (increase in Hemoglobin A1c of >/= 0.5% from previous study visit). Re-randomization will occur after the 14-day CGM wear period that will be initiated at each measurement visit.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: This initial pilot and feasibility study uses a Sequential, Multiple Assignment, Randomized Trial (SMART) design to identify acceptable and effective dietary strategies to optimize both glycemic control and weight management. The study will be done at UNC and Stanford. Sequential randomization will occur at 0, 3.5, and 7 months. Following the baseline measurement visit and two week run-in period, participants will be randomized to one of three diets (stratified by site with block size of 4). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the assigned diet is not acceptable or effective will be re-randomized (or re-assigned if only one diet remains untried). 10.5 months of follow-up time allows for evaluation of the effect of diets on initial weight loss and on early maintenance of initial weight loss. Decision criteria for re-randomization will incorporate clinical outcomes (glycemic control and weight change) and acceptability of the diet.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Accelerating Solutions to Optimize Glycemic Control and Weight Management In Young Adults With Type 1 Diabetes
Actual Study Start Date : November 12, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Hypocaloric, low carbohydrate
Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
Behavioral: Hypocaloric, low carbohydrate diet
Participants will be advised on use of a hypocaloric, low carbohydrate diet using lifestyle counseling to include motivational interviewing and problem solving skills training strategies.
Other Name: Low carbohydrate diet

Experimental: Hypocaloric, moderate low fat
Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
Behavioral: Hypocaloric, moderate low fat diet
Participants will be advised on use of a hypocaloric, moderate low fat diet using lifestyle counseling to include motivational interviewing and problem solving skills training strategies.
Other Name: Low fat diet

Experimental: Mediterranean, no caloric restriction
Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
Behavioral: Mediterranean diet, no caloric restriction
Participants will be advised on use of a healthy Mediterranean-based eating plan using lifestyle counseling to include motivational interviewing and problem solving skills training strategies.
Other Name: Mediterranean diet




Primary Outcome Measures :
  1. Change in weight - Randomization 1 [ Time Frame: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit ]
    Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

  2. Change in weight - Randomization 2 [ Time Frame: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit ]
    Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

  3. Change in weight - Randomization 3 [ Time Frame: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit ]
    Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

  4. Change in HbA1C - Randomization 1 [ Time Frame: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit ]
    HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

  5. Change in HbA1C - Randomization 2 [ Time Frame: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit ]
    HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

  6. Change in HbA1C - Randomization 3 [ Time Frame: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit ]
    HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

  7. Difference in Percent Time Spent in Hypoglycemia - Randomization 1 [ Time Frame: 2 weeks of wear from Baseline Visit (-14 Days), 2 weeks of wear from 3 Month (Measurement 2) Visit ]
    Change in the percent of time spent in hypoglycemia during Continuous Glucose Monitor (CGM) wear time will be assessed between the two weeks of wear from CGM insertion at Baseline Visit (-14 days) and the two weeks of wear from the insertion of the CGM at Measurement Visit 2.

  8. Difference in Percent Time Spent in Hypoglycemia - Randomization 2 [ Time Frame: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit ]
    Change in the percent of time spent in hypoglycemia during CGM wear time will be assessed between the two weeks of wear from CGM insertion at Measurement 2 Visit and from CGM insertion at Measurement 3 Visit.

  9. Difference in Percent Time Spent in Hypoglycemia - Randomization 3 [ Time Frame: 2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) Visit ]
    Change in the percent of time spent in hypoglycemia during CGM wear time will be assessed between the two weeks of wear from CGM insertion at Measurement 3 Visit and from CGM insertion at Measurement 4 Visit.


Secondary Outcome Measures :
  1. Change in percent body fat - Randomization 1 [ Time Frame: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit ]
    Percent fat mass and percent fat free mass will be measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this time three-and-a-half-month time period.

  2. Change in percent body fat - Randomization 2 [ Time Frame: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit ]
    Percent fat mass and percent fat free mass will be measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this three-and-a-half-month time period.

  3. Change in percent body fat - Randomization 3 [ Time Frame: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit ]
    Percent fat mass and percent fat free mass will be measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this three-and-a-half-month time period.

  4. Difference in time spent within target blood glucose range - Randomization 1 [ Time Frame: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit ]
    Change in percent of time spent in a pre-defined range of relative euglycemia (for a person with Type 1 diabetes) during CGM wear time, will be assessed between the two weeks of wear from CGM insertion at Baseline Visit (-14 days) and the two weeks of wear from CGM insertion at Measurement Visit 2.

  5. Difference in time spent within target blood glucose range - Randomization 2 [ Time Frame: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit ]
    Change in percent of time spent in a pre-defined range of relative euglycemia (for a person with Type 1 diabetes) during CGM wear time, will be assessed between the two weeks of wear from CGM insertion at Measurement 2 Visit and from CGM insertion at Measurement 3 Visit.

  6. Difference in time spent within target blood glucose range - Randomization 3 [ Time Frame: 2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) Visit ]
    Change in percent of time spent in a pre-defined range of relative euglycemia (for a person with Type 1 diabetes) during CGM wear time, will be assessed between the two weeks of wear from CGM insertion at Measurement 3 Visit and from CGM insertion at Measurement 4 Visit.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals 19-30 years old at enrollment
  • History of Type 1 diabetes for greater than one year
  • Latest hemoglobin A1c less than 13%
  • BMI of 27-39

Exclusion Criteria:

  • Individuals with other metabolic disorders, unstable thyroid disease, diagnosed eating disorder, prohibitive strict dietary restrictions or those with other serious condition that renders participation inappropriate
  • Individuals who have experience diabetic ketoacidosis (DKA) or severe hypoglycemia requiring outside assistance in the last 6 months
  • Females who are pregnant, breastfeeding, have delivered a baby in the last 12 months, or are planning to become pregnant during the study period.
  • Individuals unwilling to follow any of the three study diets
  • Individuals who monitor blood glucose less than 3 times a day

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): NCT03651622


Contacts
Layout table for location contacts
Contact: Joan M Thomas, MS, RD 919-843-8423 joan_thomas@unc.edu
Contact: Katie Souris, MPH 919-966-5635 kjsouris@unc.edu

Locations
Layout table for location information
United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Marissa Town    513-910-0081    marissah@stanford.edu   
Principal Investigator: David Maahs, MD, PhD         
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Katie Souris    919-966-5635    kjsouris@unc.edu   
Contact: Joan Thomas    919-843-8423    joan_thomas@unc.edu   
Principal Investigator: Elizabeth J Mayer-Davis, PhD         
Sub-Investigator: Sue Kirkman, MD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Layout table for investigator information
Principal Investigator: Elizabeth Mayer-Davis, PhD UNC Chapel Hill
Principal Investigator: David M Maahs, MD, PhD Stanford University
Principal Investigator: Richard Pratley, MD Florida Hospital, Translational Research Institute

Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03651622     History of Changes
Other Study ID Numbers: 18-1025
1DP3DK113358-01 ( U.S. NIH Grant/Contract )
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of North Carolina, Chapel Hill:
Type 1 diabetes
T1D
Type 1 diabetes mellitus (T1DM)
weight management
overweight
obese

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Overweight
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms
Autoimmune Diseases
Immune System Diseases