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Intermittent Fasting for the Treatment of Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT05860413
Recruitment Status : Recruiting
First Posted : May 16, 2023
Last Update Posted : May 16, 2023
Sponsor:
Collaborators:
American Diabetes Association
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Felicia Steger, University of Kansas Medical Center

Study Description
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Brief Summary:
To test whether a lifestyle program featuring one of two forms of intermittent fasting (IER or TRE) can feasibly and effectively improve glycemia in patients with type 2 diabetes, and potentially induce diabetes remission.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Intermittent energy restriction (IER) Behavioral: Time Restricted Eating (TRE) Not Applicable

Detailed Description:
Intermittent energy restriction (IER) and time-restricted eating (TRE) are two distinct forms of intermittent fasting which have yet to be compared for the treatment of type 2 diabetes. Investigators will test whether a comprehensive, intensive lifestyle program featuring each of these intermittent fasting approaches is feasible and effective for improving glycemic control in patients diagnosed with type 2 diabetes within the past 10 years. Both interventions will be delivered over one year in three phases: (1) a 12-week weight loss program featuring weekly group meetings, (2) a 12-week weight maintenance program featuring biweekly group meetings, and (3) a 6-month low-contact follow up period featuring monthly check-ins.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intermittent Fasting for the Treatment of Type 2 Diabetes Mellitus
Actual Study Start Date : January 24, 2023
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intermittent energy restriction (IER)
Intermittent fasting using a very-low energy diet (VLED; 550-800 kcal/d) 2-3 days per week
 Behavioral: Intermittent energy restriction (IER)
During Phase 1 (Weight Loss), participants will follow a very-low energy diet (VLED; 550-800 kcal/d) 2-3 days per week. On other days, participants do not have a specific kcal goal (non-fasting days). After Phase 1, IER participants will be instructed to follow a VLED 1-2 days per week as needed for weight maintenance.
Experimental: Time-restricted eating (TRE)
Intermittent fasting using an 8-hour eating period.
 Behavioral: Time Restricted Eating (TRE)
Participants will eat within an 8-hour period most days (at least 5 days per week). All foods and beverages containing calories will be restricted to this 8-hour period but calorie-free beverages (coffee, tea, diet soda, etc.) are allowed at any time. TRE participants will follow healthy eating guidelines for weight loss during Phase 1 but not follow a specific kcal prescription or restrict intake thereafter.


Outcome Measures
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Primary Outcome Measures :
  1. Retention [ Time Frame: 52 weeks ]
    Feasibility of IER and TRE over one year assessed by retention (# completed / # enrolled) and attendance (# classes attended / # classes offered).

  2. Adherence to diet protocols [ Time Frame: Weekly from baseline to 52 weeks ]
    Acceptability of IER and TRE over one year as assessed by compliance to program recommendations (# weeks adhered / # study weeks).


Secondary Outcome Measures :
  1. HbA1c [ Time Frame: Change from baseline to 24 weeks ]
    Estimate the effects for both IER and TRE on long-term glycemic control assessed via HbA1c

  2. Oral Glucose Tolerance Test [ Time Frame: Change from baseline to 24 weeks ]
    Estimate the effects for both IER and TRE on fasting and 3 hr glucose result.

  3. Isulin resistance [ Time Frame: Change from baseline to 24 weeks ]
    Estimate the effects for both IER and TRE on insulin resistance estimated by the oral minimal model during a mixed meal tolerance test

  4. Insulin sensitivity [ Time Frame: Change from baseline to 24 weeks ]
    Estimate the effects for both IER and TRE on insulin sensitivity estimated by the oral minimal model during a mixed meal tolerance test


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosed with type 2 diabetes in the past 10 years.
  2. Age 21-65 years
  3. BMI of 25 - 45 kg/m2
  4. HbA1c of 6.7-9.5%, or those with A1c of <6.7% on glucose-lowering medications
  5. Ability to participate in a graduated physical activity program
  6. Clearance from study physician.

Exclusion Criteria:

  1. Inability to attend health education meetings.
  2. Weight change of >=5% in the previous 3 months.
  3. Addition of new antihyperglycemic or weight-reducing medication in the previous 2 months.
  4. Serious medical risk such as ongoing treatment for cancer, uncontrolled hypertension, recent cardiac event, or other medical condition presenting acute risk of participation in a lifestyle change program.
  5. Untreated depression or anxiety, or increase in associated medications in the previous 3 months.
  6. Current participation in another lifestyle change intervention, such as a tobacco cessation program or physical activity program.
  7. Pregnancy or lactation within the previous six months
  8. Weight of >450 lbs
  9. Currently taking medications that may result in hypoglycemia during fasting and unwilling to stop prior to the study
Contacts and Locations
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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): NCT05860413


Contacts
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Contact: Felicia Steger, PhD 913-735-5411 fsteger@kumc.edu
Contact: Annie Eller, RD 913-735-5411 aeller2@kumc.edu

Locations
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United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Felicia Steger, PhD    913-735-5411    fsteger@kumc.edu   
Contact: Annie Eller, RD    913-735-5411    aeller2@kumc.edu   
Principal Investigator: Felicia Steger, PhD         
Sponsors and Collaborators
University of Kansas Medical Center
American Diabetes Association
National Institutes of Health (NIH)
More Information
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Responsible Party: Felicia Steger, Assistant Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT05860413    
Other Study ID Numbers: STUDY00149127
First Posted: May 16, 2023    Key Record Dates
Last Update Posted: May 16, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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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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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases