Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03710798
Other study ID # 2018/307
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2018
Est. completion date January 10, 2019

Study information

Verified date February 2019
Source Central Norway Regional Health Authority
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Lipedema is a chronic disease with unproportional, symmetrical fat accumulation in the lower extremities. Patients experience pain in affected areas, and reduced quality of life. Today's treatment is physiotherapy and surgery (liposuction). Recent research shows that ketogenic-diet with low carbohydrate, high fat (LCHF) conant can lead to reduced pain, increased quality of life and change in body composition. Goals: Investigate the effect of LCHF diet on pain, quality of life and body composition.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date January 10, 2019
Est. primary completion date January 10, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- weight stable over the last three months (+ 2-3 kg)

- not currently dieting to loose weight.

- willing to meet for weekly follow-ups during the intervention and the reintroduction of a regular diet.

- sign an informed consent before entering the study.

Exclusion Criteria:

- pregnant or breast feeding

- history of infectious diseases

- medication known to affect obesity

- enrolment in any other obesity treatment

- have had a bariatric surgery

- history of psychological disorders

- mentally disabled

- not mastering a Scandinavian language

- having a malign disease or any disease that leads to dietary advice that is not consistent with intervention advices in the study

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Low carbohydrate high fat diet
Energy balanced low carbohydrate high fat diet during 6 weeks. Then 6-week reintroduction of a healthy normal diet

Locations

Country Name City State
Norway Obesity Clinic, St Olavs Hospital Trondheim

Sponsors (3)

Lead Sponsor Collaborator
Central Norway Regional Health Authority St. Olavs Hospital, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lymphedema Quality of Life questionnaire 6 weeks
Primary Pain indicated on a visual analog scale 6 weeks
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04517591 - Reducing Sedentary Time in Bariatric: The Take a STAND for Health Study N/A
Active, not recruiting NCT04583683 - Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities N/A
Completed NCT01550601 - Impact of the Preservation of the Gastric Antrum in the Technique of Sleeve Gastrectomy for the Treatment of the Morbid Obesity N/A
Completed NCT03638843 - Endoscopic Gastric Mucosal Devitalization (GMD) as a Primary Obesity Therapy - Part 2 N/A
Recruiting NCT05917795 - Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates N/A
Completed NCT03339791 - Sleeve Versus Bypass in Older Patients: a Randomized Controlled Trial N/A
Recruiting NCT05711758 - Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure
Not yet recruiting NCT04209842 - Effectiveness Gastric Balloon in Obese Adolescents N/A
Recruiting NCT03100292 - Korean OBEsity Surgical Treatment Study N/A
Active, not recruiting NCT04357119 - Common Limb Length in One-anastomosis Gastric Bypass N/A
Completed NCT03210207 - Gastric Plication in Mexican Patients N/A
Completed NCT02590406 - EPO2-A: Evaluation of Pre-Oxygenation in Morbid Obesity: Effect of Position and Positive Pressure Ventilation N/A
Completed NCT01840020 - BAR-trial: Bioavailability of Ethanol Following Bariatric Surgery
Completed NCT01183975 - Swedish Adjustable Gastric Banding Observational Cohort Study N/A
Completed NCT03872024 - Performances Evaluation of New FibroScan Probes Dedicated to Morbidly Obese Patients N/A
Terminated NCT05993169 - Body Composition Optimization Intervention RCT N/A
Not yet recruiting NCT05974995 - Robotic-assisted Versus Conventional Laparoscopic Surgery in Obese Patients With Early Endometrial Cancer N/A
Recruiting NCT05554016 - The UFO (Ultra Processed Foods in Obesity) Project
Completed NCT05519423 - Investigation of the Effectiveness of Whatsapp-Based Physical Activity Incentive Program in Morbidly Obese Individuals N/A
Not yet recruiting NCT05499949 - The Franciscus Obesity NASH Study