Effect of Cryolipolysis on Insulin Resistance

NCT ID: NCT06223490

Last Updated: 2024-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-01-30

Brief Summary

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Diabetes mellitus (DM) is a complex chronic illness associated with a state of high blood glucose level, or hyperglycemia, occurring from deficiencies in insulin secretion, action, or both.

Diabetes mellitus is the name given to a wide spectrum group of disorders characterized by raised plasma glucose.Type 1 diabetes is characterized by an absolute insulin deficiency due to autoimmune destruction of insulin producing beta cells in the pancreas.

most adults with diabetes have type 2, characterized by a relative insulin secretory defect, and target tissue resistance to the effects of insulin.

Detailed Description

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Diabetes is one of the most important health problems and chronic metabolic diseases requiring critical care.The number of people with diabetes has risen from 108 million in 1980 to 422 million in 2014.

Type 2 diabetes mellitus is a common and increasingly prevalent disease and is thus a major public health concern worldwide. The International Diabetes Federation estimates that there are approximately 387 million people diagnosed with diabetes across the globe.

The clinical diagnosis of diabetes is reliant on either one of the four plasma glucose (PG) criteria: elevated (i) fasting plasma glucose (FPG) (\>126 mg/dL), (ii) 2 h PG during a 75-g oral glucose tolerance test (OGTT) (\>200 mg/dL), (iii) random PG (\>200 mg/dL) with classic signs and symptoms of hyperglycemia, or (iv) hemoglobin A1C level \>6.5%.

The principal tissues affected by insulin resistance are liver, muscle and fat. In the liver this impaired insulin related inhibition of hepatic gluconeogenesis results in increased hepatic glucose output, exacerbating hyperglycemia.

In muscle, reduced transport of carbohydrates into muscle combined with lipid deposition in muscle cells leads toimpaired exercise ability and lowered threshold for tiredness with exercise. In fat tissue, there is impaired insulin-mediated inhibition of hormone dependent lipase, with breakdown of lipids to free fatty acids and glycerol, contributing to the dyslipidemia. With the rise in diabetes prevalence, researchers have increasingly investigated treatments intended to improve health and quality of life. People are much more likely to achieve metabolic control when they adhere to recommended diets, medications and exercise behaviors.

Cryolipolysis (CoolSculpting, Zeltiq, Pleasanton, CA) is a novel method of selective removal of fat with cooling. This technique is basedon the concept that fat cells are more sensitive to cold than the surrounding tissue. Prior studies and observations have demonstrated that cold exposure can induce selective damage to the subcutaneous fat via induction of panniculitis, resulting in reduction in the superficial fat layer of the skin

Conditions

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Type 2 Diabetes Mellitus in Obese Cryotherapy Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cryolipolysis Group

About 30 obese females with type 2 diabetes and will face cryolypolysis in addition to exercise therapy treatment

Group Type ACTIVE_COMPARATOR

Cryolipolysis

Intervention Type PROCEDURE

To investigate the Effect of Cryolipolysis On insulin resistance and In adult type 2 female patients.

Group of Exercise

About 30 obese females with type 2 diabetes and will face exercise therapy treatment only.

Group Type ACTIVE_COMPARATOR

Cryolipolysis

Intervention Type PROCEDURE

To investigate the Effect of Cryolipolysis On insulin resistance and In adult type 2 female patients.

Interventions

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Cryolipolysis

To investigate the Effect of Cryolipolysis On insulin resistance and In adult type 2 female patients.

Intervention Type PROCEDURE

Other Intervention Names

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Exercise therapy

Eligibility Criteria

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Inclusion Criteria

* Patients with incidence of diabetes 5 years ago.
* Patient fasting glucose level is more than 140 mg/dL.
* Age will be ranged from 35 to 45 years
* Body mass index between 25 and 30.
* All patients are medically controlled
* All patients have the same medical care.
* All patients will receive a good explanation of treatment procedures.

Exclusion Criteria

* Patients dependent on insulin.
* Renal failure.
* Myocardial infractions.
* Cardiovascular problems.
* Neurological disorders.
* Patients with orthopedic problems (e.g mal or incomplete union of fracture, ankle sprains.
* Abdominal hernia
* Skin disease
* Unstable cases
Minimum Eligible Age

35 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Noura Ramadan Fahmy

Resident of Physical therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Akram Abd El Aziz, Assist.Prof

Role: STUDY_CHAIR

Cairo University

Locations

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Faculty of Physical Therapy, Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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NOURA RAMADAN, MSC

Role: CONTACT

+201158577826

Facility Contacts

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Mona AbdelWahab, Lecturer

Role: primary

+201117203904

Other Identifiers

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Noura Fahmy

Identifier Type: -

Identifier Source: org_study_id

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