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Low Calorie Diet and Diabetes (LCD)

Primary Purpose

Diabetes Mellitus Type 2, Dyslipidemia, Non-alcoholic Fatty Liver Disease

Status

Enrolling by invitation

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Low calorie diet followed by life style intervention

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men and women of age 18-65 years at screening.
Diagnosis of type 2 diabetes mellitus.
BMI > 30 kg/m2.
HbA1c > 52 mmol/mol.
Stable weight ± 5% for at least 12 weeks prior to screening.
Informed consent must be obtained by each subject before enrollment in the study.

Exclusion Criteria:

Pregnant or brest-feeding women or women who are planning to become pregnant or breast-feeding.
Type 1 diabetes mellitus or secondary forms of diabetes including pancreatic injury, cushing syndrome etc.
Clinically significant diabetic complications
Clinically symptomatic gastrointestinal or hepatic disease.
History of gastric bypass, antrectomy or small bowel disease.
History of pancreatitis.
Myocardial infarction within the past six months.
Symptomatic ischemic heart disease, heart failure or stroke.
Atrial fibrillation.
Patients on treatment with warfarin.
Diagnosed and/or treated malignancy within the past 5 years.
Any of the following laboratory abnormalities at screening:
- ALT and/or AST > 3 times the upper limit of the normal range.
- Serum creatinine levels > 130 µmol/l.
- Clinically significant TSH out of the normal range.
- Uric acid > 50% above normal level.
History of alcohol or other substance abuse within the past 2 years.
Psychiatric disease including eating disorder, bulimia nervosa, depression, anxiety, psychotic disease.
Potentially unreliable patients and those judged by the investigator to be unsuitable for the study.

Sites / Locations

Karolinska University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Weight reduction

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline in HbA1c (mmol/mol) at 12 and 24 months

Secondary Outcome Measures

Change from Baseline in BMI (kg/m2) at 7 weeks, 6,12, and 24 months

Change from Baseline in Liver Fat (Controlled Attenuation Parameter, db/m) at 7 weeks, 6, 12 and 24 months

Liver Fat Measured by Fibroscan

Change from Baseline in Cholesterol (mmo/l) and Triglycerides (mmol/l) at 7 weeks, 6, 12 and 24 months

Change from Baseline in 2-hour Glucose (mmol/l) and Insulin (mU/l) by Glucose tolerance test at 7 weeks, 6, 12 and 24 months

Glucose tolerance test: oral administration of 75 g Glucose

Full Information

NCT ID

NCT02498990

First Posted

July 3, 2015

Last Updated

February 17, 2021

Sponsor

Karolinska University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02498990

Brief Title

Low Calorie Diet and Diabetes

Acronym

LCD

Official Title

Long-term Metabol Control After Weight Reduction With Low Calorie Diet in Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Enrolling by invitation

Study Start Date

August 2015 (undefined)

Primary Completion Date

February 2024 (Anticipated)

Study Completion Date

August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary hypothesis is to investigate whether a low calorie diet for 7 weeks followed by continuous lifestyle advice is an effective option to achieve an improvement in glucose control as measured by HbA1c after 52 and 104 weeks as compared to baseline values in obese type 2 diabetes patients on either tablet or insulin treatment. The secondary hypothesis is to investigate whether the weight reduction therapy also has significant impact on various anthropometric, clinical and metabolic parameters associated with obesity.

Detailed Description

This is a prospective study on the impact of low calorie diet followed by a weight maintenance program on 12 and 24 month glucose control in a cohort of patients with obesity and diabetes mellitus. The study will consist of 3 phases: Screening period (up to 12 weeks). Low calorie diet weeks 1-9. Seven weeks of low-calorie diet including 800 kcal/day followed by 2 weeks of gradual introduction of normal diet of eventually 1500-2000 kcal/day, i.e. 600 kcal/day deficit, based on present body weight and sex. At entry of the LCD-period, all medication for diabetes mellitus, with the exception of metformin and insulin, will be removed. During the LCD-period, insulin treatment will gradually be reduced and, if possible, withdrawn. Patients will perform daily self-monitoring of fasting and post-prandial plasma glucose. At each visit, which will take place once a week, the patients will see a physician, a nurse and a dietician. The patients will be given specific advice to increase their physical activity. Patients will remain on medication for dyslipidemia. Blood pressure will be measured at each visit and in case of blood pressure < 110/70 mmHg and/or in case of symptoms associated with hypotension including dizziness, medication for hypertension will be reduced or removed. Weight-maintenance program weeks 10-52. Follow up visits at months 15, 18, 21 and 24.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus Type 2, Dyslipidemia, Non-alcoholic Fatty Liver Disease, Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Weight reduction

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Low calorie diet followed by life style intervention

Intervention Description

Low calorie diet of 800 kcal/day for 7 weeks. Life style intervention for the remaining study period

Primary Outcome Measure Information:

Title

Change from Baseline in HbA1c (mmol/mol) at 12 and 24 months

Time Frame

12 months and 24 months

Secondary Outcome Measure Information:

Title

Change from Baseline in BMI (kg/m2) at 7 weeks, 6,12, and 24 months

Time Frame

7 weeks, 6, 12 and 24 months

Title

Change from Baseline in Liver Fat (Controlled Attenuation Parameter, db/m) at 7 weeks, 6, 12 and 24 months

Description

Liver Fat Measured by Fibroscan

Time Frame

7 weeks, 6, 12 and 24 months

Title

Change from Baseline in Cholesterol (mmo/l) and Triglycerides (mmol/l) at 7 weeks, 6, 12 and 24 months

Time Frame

7 weeks, 6,12 and 24 months

Title

Change from Baseline in 2-hour Glucose (mmol/l) and Insulin (mU/l) by Glucose tolerance test at 7 weeks, 6, 12 and 24 months

Description

Glucose tolerance test: oral administration of 75 g Glucose

Time Frame

7 weeks, 6,12, 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and women of age 18-65 years at screening. Diagnosis of type 2 diabetes mellitus. BMI > 30 kg/m2. HbA1c > 52 mmol/mol. Stable weight ± 5% for at least 12 weeks prior to screening. Informed consent must be obtained by each subject before enrollment in the study. Exclusion Criteria: Pregnant or brest-feeding women or women who are planning to become pregnant or breast-feeding. Type 1 diabetes mellitus or secondary forms of diabetes including pancreatic injury, cushing syndrome etc. Clinically significant diabetic complications Clinically symptomatic gastrointestinal or hepatic disease. History of gastric bypass, antrectomy or small bowel disease. History of pancreatitis. Myocardial infarction within the past six months. Symptomatic ischemic heart disease, heart failure or stroke. Atrial fibrillation. Patients on treatment with warfarin. Diagnosed and/or treated malignancy within the past 5 years. Any of the following laboratory abnormalities at screening: ALT and/or AST > 3 times the upper limit of the normal range. Serum creatinine levels > 130 µmol/l. Clinically significant TSH out of the normal range. Uric acid > 50% above normal level. History of alcohol or other substance abuse within the past 2 years. Psychiatric disease including eating disorder, bulimia nervosa, depression, anxiety, psychotic disease. Potentially unreliable patients and those judged by the investigator to be unsuitable for the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Johan Hoffstedt, MD, PhD

Organizational Affiliation

Karilonska University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Karolinska University Hospital

City

Stockholm

ZIP/Postal Code

14186

Country

Sweden

12. IPD Sharing Statement

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Low Calorie Diet and Diabetes

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