Metabolic and Hormonal Effects of 5:2 Intermittent Fasting

NCT02450097 | Completed DMC

• 1 other identifier: Dnr2013/1618-31/3
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Diabetes Type 2

Outcome Measures

Primary Outcomes (1)

• Change from baseline in fasting serum insulin in 6 months.

  Serum insulin will be measured using a radioimmunoassay (RIA; Pharmacia insulin RIA 100, Pharmacia Diagnostics, Uppsala, Sweden).

  6 months

Study Arms (1)

Lifestyle counseling

OTHER

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

Interventions

Caloric restriction OTHER

Lifestyle counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Kerstin Brismar, Professor

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D/Professor

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: May 21, 2015
• Study Start: December 1, 2013
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 15, 2017

Record last verified: 2017-12

Locations

SE (1)