Effect of Cryolipolysis on Insulin Resistance

January 23, 2024 updated by: Noura Ramadan Fahmy, Cairo University

Effect of Cryolipolysis on Insulin Resistance in Type 2 Diabetic Females With Abdominal Obesity

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Faculty of physical therapy, Cairo University
        • Contact:
        • Principal Investigator:
          • Maha Saber, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cryolipolysis Group
About 30 obese females with type 2 diabetes and will face cryolypolysis in addition to exercise therapy treatment
Procedure: Cryolipolysis
To investigate the Effect of Cryolipolysis On insulin resistance and In adult type 2 female patients.
Other Names:
  • Exercise therapy
Active Comparator: Group of Exercise
About 30 obese females with type 2 diabetes and will face exercise therapy treatment only.
Procedure: Cryolipolysis
To investigate the Effect of Cryolipolysis On insulin resistance and In adult type 2 female patients.
Other Names:
  • Exercise therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin fold thickness and estimation of total body fat
Time Frame: 3 months

Estimation of body fat for all cases and is done by measuring these parameters :

weight in kilograms, height in meters as weight and height will be combined to report BMI in kg/m^2.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Akram Abd El Aziz, Assist.Prof, Cairo university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

January 20, 2024

Study Completion (Estimated)

January 30, 2024

Study Registration Dates

First Submitted

January 6, 2024

First Submitted That Met QC Criteria

January 23, 2024

First Posted (Estimated)

January 25, 2024

Study Record Updates

Last Update Posted (Estimated)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Noura Fahmy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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