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Type 2 Diabetes MellitusFAIRNCT05295160

Fasting-Associated Immune-metabolic Remission of Diabetes

A study testing weight loss by very low energy diet intake which may differ in protein or carbohydrate content in people with Type 2 Diabetes Mellitus and Obesity, run by Charite University, Berlin, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

People with a body mass index above 28 kg/m² and an onset of type 2 diabetes within the last 4 years had a remission (HbA1c <6.5% without medication) of diabetes in over 80% upon weight loss of 15 kg. Longer duration of diabetes reduced the chance of remission. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Type 2 Diabetes Mellitus, Obesity
What is being tested?
weight loss by very low energy diet intake which may differ in protein or carbohydrate content
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteGermany
Study dates
25 Sep 2020to 30 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 2 diabetes diagnosed less than 4 or over 8 years, before study,
  • BMI > 28 kg/m²,
  • willingness to follow weight loss diet,

Who cannot join

  • consuming disease,
  • intolerance for very low calorie formula diet,
  • known severe hepatic disease or liver cirrhosis,
  • type 1 diabetes,
  • severe disease of kidney or heart,
  • advanced diabetic retinopathy,
Show all 10Show fewer
  • intake of glucocorticoids,
  • drug or alcohol abuse,
  • weight loss of >5 kg in the last 3 month,
  • eating disorder

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Charité Campus Benjamin Franklin

    Berlin, 12203

Other trials in Germany

About this study

Official title: Fasting-Associated Immune-metabolic Remission of Diabetes Type 2

People with a body mass index above 28 kg/m² and an onset of type 2 diabetes within the last 4 years had a remission (HbA1c <6.5% without medication) of diabetes in over 80% upon weight loss of 15 kg. Longer duration of diabetes reduced the chance of remission. The investigators will test whether there is a difference in remission upon weight loss of 15 kg using formula low calorie diets between subjects with a diabetes duration of <4 years vs. >8 years and oral treatment as primary end points. The immune metabolic programming of circulating monocytes will be investigated in detail regarding trained innate immunity and the endocrine responses will be determined using meal challenge tests.

Read the detailed description

A remission of type 2 diabetes can be achieved in over 80% of people with a diagnosis within the last 4 years and overweight or obesity by weight loss of 15 kg. The mechanisms involve an improvement of insulin sensitivity and thereby insulin requirements and a regain of the function of insulin secreting beta cells. Longer duration of type 2 diabetes appears to impair the capacity of beta cell to regenerate. At present it is not possibe to predict success of the weight loss at an early time point. The investigators therefore aim to identify early markers of responders. It is unclear how the weight loss induces the remission in responders. Immune cells are known to contribute to insulin resistance by regulating adipose tissue function and hepatic and skeletal muscle metabolism by releasing cytokines. The inborn immune system is known to adapt to external stimuli by the process of trained immunity and is thought to contribute to insulin resistance and the dysfunction of beta-cells. The investigation will analyze the programming state of innate immune cells in detail in the course of diabetes remission. In addition, islet hormone responses to challenge tests will be performed to assess their function in detail.

Being tested
weight loss by very low energy diet intake which may differ in protein or carbohydrate content
Keywords
type 2 diabetes mellitus in obese, insulin secretion, innate immunity, monocyte programming, remission of type 2 diabetes, weight loss
Medical subject headings
Diabetes Mellitus, Type 2, Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • weight loss by very low energy diet intake which may differ in protein or carbohydrate contentBehavioural

    The anthropometric, endocrine and metabolic status is tested before, after 7 days and after 15 kg weight loss

Study groups in NCT05295160
Study groupRoleWhat they receive
type 2 diabetes - less than 4 years durationOtherPatients with a duration of less than 4 years since diagnosis of type 2 diabetes, BMI > 28 kg/m², non-insulin treated who agree to loose 15 kg body weight by eating a very low calorie formula diet of 800 kcal/day for men and 600 kcal/day for women. The duration of the diet is until the weight loss is achieved.
Receives: Behavioral: weight loss by very low energy diet intake which may differ in protein or carbohydrate content
type 2 diabetes - more than 8 yearsOtherPatients with a duration of more than 8 years since diagnosis of type 2 diabetes, BMI > 28 kg/m², non-insulin treated who agree to loose 15 kg body weight by eating a very low calorie formula diet of 800 kcal/day for men and 600 kcal/day for women. The duration of the diet is until the weight loss is achieved.
Receives: Behavioral: weight loss by very low energy diet intake which may differ in protein or carbohydrate content

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Concentration of fasting blood glucose < 126 mg/deciliter

    Remission of type 2 diabetes defined by a concentration of a fasting blood glucose < 126 mg/deciliter without diabetes medication

    Measured: 3 month

Secondary outcomes (2)

  1. Immune-metabolic profile and programing of innate immunity

    Changes of cluster of differentiation 4/cluster of differentiation antigen 45 circulating immune cells in percent of CD4+ cells measured by flow cytometry in blood.

    Concentrations of TNFalpha in pg/ml, changes of Momocyte Chemoattractant Protein-1 in pg/ml.

    Measured: before, after 7 days and after 3 month

  2. Composition of the microbiome

    Percent changes in firmicutes in stool,

    Measured: before, after 7 days and after 3 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2022
  2. Study start25 Sep 2020
  3. Primary completion31 Dec 2022
  4. Study completion30 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Obese people with type 2 diabetes with a duration of less then 4 years will be compared with people with type 2 diabetes for more than 8 years regarding their capability to achieve remission of type 2 diabetes in response to a weight loss of 15kg achived using very low calorie intake
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05295160
Sponsor's protocol ID
FAIR-EFSD
Acronym
FAIR
Status last verified
Aug 2023
First submitted
25 Sep 2020
Last updated
30 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5.

    PubMed 29221645

  • Steven S, Hollingsworth KG, Al-Mrabeh A, Avery L, Aribisala B, Caslake M, Taylor R. Very Low-Calorie Diet and 6 Months of Weight Stability in Type 2 Diabetes: Pathophysiological Changes in Responders and Nonresponders. Diabetes Care. 2016 May;39(5):808-15. doi: 10.2337/dc15-1942. Epub 2016 Mar 21.

    PubMed 27002059

  • Jahn SL, Demircan K, Chillon TS, Schuppelius B, Lalama E, Zhang J, Hackler J, Ruther K, Csanalosi M, Christ A, Latz E, Pivovarova-Ramich O, Kabisch S, Mai K, Pfeiffer AFH, Schomburg L. Trace element dynamics following low-calorie formula diet and their association with glycaemic traits. Clin Nutr. 2026 Aug;63:106693. doi: 10.1016/j.clnu.2026.106693. Epub 2026 May 26.

    PubMed 42269399

Questions about this trial

What is this clinical trial studying?

A study testing weight loss by very low energy diet intake which may differ in protein or carbohydrate content in people with Type 2 Diabetes Mellitus and Obesity, run by Charite University, Berlin, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentration of fasting blood glucose < 126 mg/deciliter (time frame: 3 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05295160, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.

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