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Trial record 12 of 31 for:    IGFBP2

Metabolic and Hormonal Effects of 5:2 Intermittent Fasting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02450097
Recruitment Status : Completed
First Posted : May 21, 2015
Last Update Posted : December 15, 2017
Information provided by (Responsible Party):
Kerstin Brismar, Karolinska University Hospital

Brief Summary:

The aim of the present study is to investigate in subjects with and without type 2 diabetes the effect of calorie restriction (CR) according to the 5:2 method for 6 months (every week two days caloric fasting with 500 calories for women and 600 calories for men and five days of normal caloric intake) on risk markers for cardiovascular disease and certain cancers (hyperinsulinemia, insulin resistance, IGF-1, IGFBP-1, IGFBP-2, glucose, HbA1c, blood lipids, markers of inflammation and oxidative stress) and on peptides regulating glucose metabolism and appetite as well as the effect on blood pressure, body composition, waist- and hip- circumference. DNA will also be analysed at the start and after 6 months to investigate any epigenetic effects.

After completed study there will be a follow up after additional 6 months.

Condition or disease Intervention/treatment Phase
Obesity Diabetes Type 2 Other: Caloric restriction Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Metabolic and Hormonal Effects of 5:2 Intermittent Fasting in Patients With Type 2 Diabetes and Subjects With Adiposity
Study Start Date : December 2013
Actual Primary Completion Date : November 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Lifestyle counseling

Intermittent Caloric restriction in 3 Groups:

I- 40 patients with diabetes type 2 BMI 25.1-37 II- 40 non diabetic over weight subjects with BMI 25.1-37 III- 20 non diabetic subject with BMI 23.1 - 25 and visceral fat

Other: Caloric restriction

Primary Outcome Measures :
  1. Change from baseline in fasting serum insulin in 6 months. [ Time Frame: 6 months ]
    Serum insulin will be measured using a radioimmunoassay (RIA; Pharmacia insulin RIA 100, Pharmacia Diagnostics, Uppsala, Sweden).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion criteria:

  • Age > 18 years of age.
  • Subjects without diabetes with BMI 23-37.
  • Patients with Type 2 diabetes and diabetes duration between 0.5-12 years and BMI 25-37

Exclusion criteria:

  • BMI below 23
  • Waist circumference 80 cm or less for women and 94 cm or less than for men.
  • Total fat percent of body weight less than 23%.
  • Treatment with insulin and sulfonylurea drugs.
  • Chronic kidneys disease (CKD) stage 4 and 5 (eGFR <30 ml/min).
  • Pregnancy and breast-feed.
  • Active athletes.
  • History of eating disorder.
  • Participation in another ongoing study.
  • If participant is not eligible to complete the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02450097

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Karolinska University Hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska University Hospital
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Principal Investigator: Kerstin Brismar, Professor Karolinska University Hospital

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Responsible Party: Kerstin Brismar, M.D/Professor, Karolinska University Hospital Identifier: NCT02450097     History of Changes
Other Study ID Numbers: Dnr2013/1618-31/3
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases