NCT02498990

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
17 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

8.5 years

First QC Date

July 3, 2015

Last Update Submit

February 17, 2021

Conditions

Diabetes Mellitus Type 2DyslipidemiaNon-alcoholic Fatty Liver DiseaseObesity

Outcome Measures

Primary Outcomes (1)

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

    12 months and 24 months

Secondary Outcomes (4)

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

    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

    7 weeks, 6, 12 and 24 months

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

    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

    7 weeks, 6,12, 24 months

Study Arms (1)

Weight reduction

EXPERIMENTAL
Behavioral: Low calorie diet followed by life style intervention

Interventions

Low calorie diet followed by life style interventionBEHAVIORAL

1. Low calorie diet of 800 kcal/day for 7 weeks. 2. Life style intervention for the remaining study period

Weight reduction

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, 14186, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2DyslipidemiasNon-alcoholic Fatty Liver DiseaseObesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism DisordersFatty LiverLiver DiseasesDigestive System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Johan Hoffstedt, MD, PhD

    Karilonska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 3, 2015

First Posted

July 15, 2015

Study Start

August 1, 2015

Primary Completion

February 1, 2024

Study Completion

August 1, 2025

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations

SE(1)