What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes that promote weight loss, improve cardio-metabolic function, and glycemic control include lifestyle modifications, metformin, GLP-1 receptor agonists, and SGLT2 inhibitors. Lifestyle modifications, such as diet and exercise, generally have minimal side effects but may cause mild hypoglycemia if not monitored properly. Metformin is well-tolerated but can cause gastrointestinal issues like nausea and diarrhea. GLP-1 receptor agonists can lead to gastrointestinal side effects, including nausea and vomiting, and may cause weight loss. SGLT2 inhibitors can increase the risk of urinary tract infections and genital infections. All these treatments aim to improve glycemic control and overall metabolic health.

What prior FDA approvals exist?

Several FDA-approved drugs for the treatment of Type 2 Diabetes focus on promoting weight loss, improving cardio-metabolic function, and glycemic control. GLP-1 receptor agonists, such as exenatide and liraglutide, have been shown to improve glycemic control and support weight loss. Additionally, medications like semaglutide have demonstrated significant benefits in reducing body weight and improving glycemic outcomes. These treatments align with the benefits observed in intermittent fasting, which also promotes weight loss and improves metabolic health.

What other types of research exist?

Promising novel alternatives to intermittent fasting for Type 2 Diabetes patients include: 1) Glucagon-like peptide-1 (GLP-1) receptor agonists, such as semaglutide and liraglutide, which improve glycemic control and promote weight loss. 2) Sodium-glucose cotransporter 2 (SGLT-2) inhibitors, which enhance glycemic control and have cardiovascular benefits. 3) Intensive lifestyle interventions combining diet and physical activity, which have shown significant improvements in glycemic control and weight management.

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Intermittent Fasting for Type 2 Diabetes

N/A

Recruiting

Research Sponsored by Mount Sinai Hospital, Canada

Eligibility Criteria Checklist

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

Must have

Diabetes treatment consisting of lifestyle only, metformin or dipeptidyl peptidase-4 (DPP-4) inhibitor either as monotherapy or in combination

Age 20-70 years inclusive

Must not have

Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)

Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, or previous liver transplant) or transaminases >2.5x the upper limit of normal

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 16

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying whether intermittent fasting can help people with early Type 2 Diabetes. Intermittent fasting means not eating for specific durations. It has been shown to help with weight loss and improve blood sugar levels. Researchers hope it might also help the pancreas produce insulin better.

Who is the study for?

This trial is for adults aged 20-70 with early type 2 diabetes, diagnosed within the last 10 years, who are overweight and currently managing their condition through diet, metformin or DPP-4 inhibitors. It's not open to those on complex diabetes treatments like insulin, have liver disease, a history of eating disorders or other health issues that could affect participation.

What is being tested?

The study is testing if intermittent fasting (IF), which means going without food for certain periods, can improve the function of beta-cells in the pancreas among people with early type 2 diabetes. Participants will either follow IF or maintain standard lifestyle habits to see if there's an impact on their body's ability to manage blood sugar levels.

What are the potential side effects?

Intermittent fasting may lead to hunger pangs, headaches, dizziness during fasting periods especially at the beginning. Long-term effects are unknown but it might also influence energy levels and mood.

Eligibility Criteria

Inclusion Criteria

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

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I manage my diabetes with diet, exercise, metformin, or DPP-4 inhibitors.

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I am between 20 and 70 years old.

Exclusion Criteria

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

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I have had cancer treatment other than for basal cell skin cancer in the last 5 years.

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I have significant liver issues, like jaundice or hepatitis, or my liver tests are high.

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I am not participating in any other clinical trials that involve lifestyle changes or drug treatments.

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My kidney function is low, with a filtration rate under 45 mL/min.

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I am currently being treated for diabetes with insulin or specific diabetes medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 16 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Pancreatic beta-cell function

Secondary study objectives

Fasting glucose

Other study objectives

BMI

Central abdominal fat mass on Dual X-ray Absorptiometry (DEXA)

Insulin sensitivity

+2 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

Active Control

Group I: Intermittent fasting (time restricted feeding)Experimental Treatment1 Intervention

Intermittent fasting (IF) study arm consisting of time restricted feeding with 20 hours of fasting and a 4 hour window of feeding (between 4 and 8 PM or between 5 to 9 PM).

Group II: Standard lifestyleActive Control1 Intervention

Standard lifestyle recommendation as per the Diabetes Canada guidelines, where participants are encouraged to maintain regularity in timing and spacing of means with no specific recommendations regarding the hours of fasting

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Time restricted feeding

2019

Completed Phase 2

~910

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 include lifestyle modifications, pharmacologic therapies, and insulin therapy. Lifestyle changes, such as intermittent fasting, promote weight loss and improve cardio-metabolic function and glycemic control by reducing insulin resistance and enhancing beta-cell function. Metformin, a first-line pharmacologic therapy, works by decreasing hepatic glucose production and improving insulin sensitivity. Insulin therapy, often used when other treatments are insufficient, directly increases insulin levels to help manage blood glucose. These treatments are crucial for Type 2 Diabetes patients as they target different aspects of the disease, helping to maintain blood sugar levels, reduce complications, and improve overall health.

Assessing the impact of a new delivery method of insulin on glycemic control using a novel trial design.The Danish Centre for Strategic Research in Type 2 Diabetes (DD2) Project: rationale and planned nationwide studies of genetic predictors, physical exercise, and individualized pharmacological treatment.Overcoming obstacles in risk factor management in type 2 diabetes mellitus.