Type 2 Diabetes Mellitus in ObeseNCT06223490
Effect of Cryolipolysis on Insulin Resistance
A study testing Cryolipolysis in people with Type 2 Diabetes Mellitus in Obese and Cryotherapy Effect, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 45 years, women only
- Conditions the study is for
- Type 2 Diabetes Mellitus in Obese, Cryotherapy Effect
- What is being tested?
- Cryolipolysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Abdominal hernia
- Skin disease
- Unstable cases
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy, Cairo University
Cairo
Mona AbdelWahab, Lecturer, +201117203904, monaahmed198748@yahoo.com
Maha Saber, Professor
About this study
Official title: 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.
Read the 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
- Being tested
- Cryolipolysis
- Keywords
- TII DM, Obese Females, Cryolipolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryolipolysisProcedure or surgery
Also called Exercise therapy
To investigate the Effect of Cryolipolysis On insulin resistance and In adult type 2 female patients.
| Study group | Role | What they receive |
|---|---|---|
| Cryolipolysis Group | Active comparator | About 30 obese females with type 2 diabetes and will face cryolypolysis in addition to exercise therapy treatment Receives: Procedure: Cryolipolysis |
| Group of Exercise | Active comparator | About 30 obese females with type 2 diabetes and will face exercise therapy treatment only. Receives: Procedure: Cryolipolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin fold thickness and estimation of total body fat
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start1 Nov 2023
- Primary completion20 Jan 2024 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus in ObeseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noura Ramadan Fahmy, Cairo University
- Investigators
- Akram Abd El Aziz, Assist.Prof, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223490
- Sponsor's protocol ID
- Noura Fahmy
- Status last verified
- Jan 2024
- First submitted
- 6 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cryolipolysis on Insulin Resistance in Type 2 Diabetic Females With Abdominal Obesity
- ClinicalTrials.gov ID
- NCT06223490
- Acronym / sponsor ID
- Noura Fahmy
- Keywords
- TII DM, Obese Females, Cryolipolysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 20 Jan 2024 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryolipolysis Group | Active comparator | Procedure: CryolipolysisAbout 30 obese females with type 2 diabetes and will face cryolypolysis in addition to exercise therapy treatment |
| Group of Exercise | Active comparator | Procedure: CryolipolysisAbout 30 obese females with type 2 diabetes and will face exercise therapy treatment only. |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- Patients dependent on insulin.
- Renal failure.
- Myocardial infractions.
- Cardiovascular problems.
- Neurological disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryolipolysisAlso: Exercise therapyTo investigate the Effect of Cryolipolysis On insulin resistance and In adult type 2 female patients. | Procedure or surgery | Cryolipolysis Group, Group of Exercise |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akram Abd El Aziz, Assist.Prof study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryolipolysis in people with Type 2 Diabetes Mellitus in Obese and Cryotherapy Effect, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact NOURA RAMADAN, MSC (+201158577826, drnourramadaan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin fold thickness and estimation of total body fat (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.