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Functional Medicine Approach for Type 2 Diabetes

Q: What criteria must I fulfill to qualify for this research experiment?

This research opportunity is open to 87 participants aged 21-75 with <a href="https://www.withpower.com/clinical-trials/type-2-diabetes">type 2 diabetes</a> mellitus who have been taking insulin for between 12 and 96 months, with a Total Daily Insulin Dose of no more than 150 units.

Q: What are the core aims of this experiment?

The principal purpose of this clinical trial, tracked over Baseline to 12 months, is to ascertain how many participants in each group stop using insulin with a Hemoglobin A1c &#x3C;7%. Additionally, the investigation will also consider the Reduction in insulin use-no increase in Hemoglobin A1c-12 months, Reduction in number of insulin units-no increase in Hemoglobin A1c-12 months and Evaluate <a href="https://www.withpower.com/clinical-trials/diabetes">diabetes</a> control using subject hemoglobin A1c values-12 months.

Q: Is the patient pool for this medical experiment limited to those over seventy-five years old?

The terms of this clinical trial involve recruiting individuals aged 21 to 75. By comparison, there are 206 trials targeting those younger than 18 and 1179 studies involving participants over 65 years old.

Q: Does this study currently have open enrolment?

This research endeavour is not presently enrolling new patients, as the last update was made on October 5th of 2022. However, there are many other trials recruiting across a plethora of medical fields at this moment in time.

N/A

Waitlist Available

Led By Betul Hatipoglu, MD

Research Sponsored by Keren Zhou

Eligibility Criteria Checklist

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

Must have

Diagnosis of Type 2 Diabetes

Total Daily Insulin Dose <= 150 units

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12 months

Awards & highlights

Study Summary

This trial will compare the effects of a Functional Medicine approach to diabetes care against usual care. They will look at things like cost and quality of life to see if the FM approach is more effective.

Who is the study for?

This trial is for people who have been treated with insulin for Type 2 Diabetes at the Cleveland Clinic Main Campus Endocrinology Clinics, between 12 and 96 months, using no more than 150 units of insulin daily. It's not for those with severe heart failure, cognitive issues, on certain diets or other studies, using an insulin pump, extremely high HbA1c levels (>12%), pregnant or breastfeeding women, or those with various health conditions like active cancer.Check my eligibility

What is being tested?

The study compares a Functional Medicine approach that targets root causes of diabetes through specialized testing and treatment against usual care methods. The goal is to see if this can treat or even reverse diabetes over time while also being cost-effective.See study design

What are the potential side effects?

Since the intervention involves a non-pharmaceutical approach focusing on lifestyle changes and possibly supplements based on individual assessments rather than drugs, specific side effects are not listed as they would vary greatly depending on the personalized treatments prescribed.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with Type 2 Diabetes.

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I use 150 units of insulin or less daily.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of subjects in each study arm discontinuing insulin use with Hemoglobin A1c <7%

Number of subjects in each study arm discontinuing insulin use with no increase in Hemoglobin A1c

Secondary outcome measures

Change in body weight (kg) for subjects in each study arm

Change in high density lipoprotein [HDL] (mg/dL) for subjects in each study arm

Change in low density lipoprotein [LDL] (mg/dL) for subjects in each study arm

+12 more

Trial Design

2Treatment groups

Active Control

Group I: Usual CareActive Control1 Intervention

usual care delivered by an endocrinologist

Group II: Functional Medicine + Usual CareActive Control1 Intervention

Functional Medicine in addition to usual care delivered by an endocrinologist

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Keren ZhouLead Sponsor

Betul Hatipoglu, MDPrincipal InvestigatorThe Cleveland Clinic

3 Previous Clinical Trials

464 Total Patients Enrolled

Media Library

Functional Medicine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03070106 — N/A

Type 2 Diabetes Research Study Groups: Usual Care, Functional Medicine + Usual Care

Type 2 Diabetes Clinical Trial 2023: Functional Medicine Highlights & Side Effects. Trial Name: NCT03070106 — N/A

Functional Medicine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03070106 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must I fulfill to qualify for this research experiment?

"This research opportunity is open to 87 participants aged 21-75 with type 2 diabetes mellitus who have been taking insulin for between 12 and 96 months, with a Total Daily Insulin Dose of no more than 150 units."

Answered by AI

What are the core aims of this experiment?

"The principal purpose of this clinical trial, tracked over Baseline to 12 months, is to ascertain how many participants in each group stop using insulin with a Hemoglobin A1c <7%. Additionally, the investigation will also consider the Reduction in insulin use-no increase in Hemoglobin A1c-12 months, Reduction in number of insulin units-no increase in Hemoglobin A1c-12 months and Evaluate diabetes control using subject hemoglobin A1c values-12 months."

Answered by AI

Is the patient pool for this medical experiment limited to those over seventy-five years old?

"The terms of this clinical trial involve recruiting individuals aged 21 to 75. By comparison, there are 206 trials targeting those younger than 18 and 1179 studies involving participants over 65 years old."

Answered by AI

Does this study currently have open enrolment?

"This research endeavour is not presently enrolling new patients, as the last update was made on October 5th of 2022. However, there are many other trials recruiting across a plethora of medical fields at this moment in time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Diabetes: Functional Medicine Approach vs. Usual Care

Keren Zhou 2017. "Diabetes: Functional Medicine Approach vs. Usual Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03070106.