What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes include medications like alogliptin and imeglimin, GLP-1 receptor agonists, insulin therapy, and lifestyle interventions such as intermittent fasting. Alogliptin and imeglimin are generally well-tolerated but can cause gastrointestinal issues and, rarely, pancreatitis. GLP-1 receptor agonists may lead to nausea, vomiting, and potential risk of thyroid tumors. Insulin therapy can cause hypoglycemia and weight gain. Intermittent fasting, which improves insulin sensitivity and glucose metabolism, may result in mild hypoglycemia and hunger-related discomfort. Patients should discuss these potential side effects with their healthcare provider to tailor the best treatment plan.

What prior FDA approvals exist?

FDA-approved treatments for Type 2 Diabetes that improve insulin sensitivity and glucose metabolism include metformin, which reduces hepatic glucose production and improves insulin sensitivity, and GLP-1 receptor agonists like dulaglutide and semaglutide, which enhance insulin secretion and slow gastric emptying. SGLT2 inhibitors, such as canagliflozin, reduce glucose reabsorption in the kidneys, promoting glucose excretion. While these treatments do not specifically focus on reducing caloric intake or altering food consumption timing like intermittent fasting, they play a significant role in managing blood glucose levels and improving metabolic outcomes.

What other types of research exist?

Promising alternatives to intermittent fasting for Type 2 Diabetes patients include: 1) GLP-1 receptor agonists, which improve insulin sensitivity and have a low risk of hypoglycemia; 2) SGLT2 inhibitors, which reduce blood glucose levels by increasing glucose excretion in urine; 3) Intensive lifestyle interventions, which focus on diet and exercise to achieve significant weight loss and improved glycemic control; 4) Early intensive insulin therapy (IIT), which has shown long-term benefits in glycemic control and β-cell function preservation.

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Behavioral Intervention

Intermittent Fasting for Type 2 Diabetes

N/A

Waitlist Available

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with type 2 diabetes in the past 10 years

BMI of 25 - 45 kg/m2

Must not have

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

Inability to attend health education meetings

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests whether two types of intermittent fasting can help people with type 2 diabetes manage their blood sugar better. Intermittent fasting may improve how the body uses insulin and lower blood sugar levels. Different types of intermittent fasting have been shown to reduce body weight and improve diabetes parameters such as fasting glucose and fasting insulin. The program includes different phases with varying levels of support over time.

Who is the study for?

This trial is for adults aged 21-65 with type 2 diabetes diagnosed within the last decade, having a BMI of 25-45 and an HbA1c level between 6.7-9.5%. Participants should be able to exercise and get clearance from the study physician. Those pregnant, lactating, on certain medications, or with recent serious medical issues can't join.

What is being tested?

The trial is examining if intermittent fasting—either Intermittent Energy Restriction (IER) or Time Restricted Eating (TRE)—can help control blood sugar levels in type 2 diabetes patients and possibly lead to remission of the disease.

What are the potential side effects?

Potential side effects may include feelings of hunger, weakness during fasting periods, headaches, dizziness due to changes in blood sugar levels, and possible digestive discomfort when eating resumes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was diagnosed with type 2 diabetes within the last 10 years.

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My BMI is between 25 and 45.

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I am between 21 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious health condition that could make lifestyle changes risky.

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I cannot attend health education meetings.

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I am on medication that can lower my blood sugar and cannot stop it for the study.

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I have not started treatment for depression or anxiety, nor increased my medication in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence to diet protocols

Retention

Secondary study objectives

HbA1c

Insulin sensitivity

Isulin resistance

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Time-restricted eating (TRE)Experimental Treatment1 Intervention

Intermittent fasting using an 8-hour eating period.

Group II: Intermittent energy restriction (IER)Experimental Treatment1 Intervention

Intermittent fasting using a very-low energy diet (VLED; 550-800 kcal/d) 2-3 days per week

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Time Restricted Eating (TRE)

2020

N/A

~120

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Type 2 Diabetes (T2D) include lifestyle modifications and pharmacologic therapies. Intermittent fasting (IER and TRE) improves insulin sensitivity and glucose metabolism by reducing caloric intake and altering food consumption timing. Metformin decreases hepatic glucose production and improves insulin sensitivity. GLP-1 receptor agonists enhance insulin secretion, inhibit glucagon release, and slow gastric emptying, aiding in weight loss and glycemic control. DPP-4 inhibitors prolong the action of incretin hormones, increasing insulin release and decreasing glucagon levels. Insulin therapy directly supplements insulin levels to manage blood glucose. These treatments are crucial for T2D patients as they target different aspects of glucose regulation, helping to achieve better glycemic control and reduce complications.

What next after basal insulin? Treatment intensification with lixisenatide in Asian patients with type 2 diabetes mellitus.Incretin therapies: highlighting common features and differences in the modes of action of glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors.Overcoming obstacles in risk factor management in type 2 diabetes mellitus.